NA 03.122.053Recalls & reported problems
Synthes GmbH · OUTER SLEEVE FOR INSERTION GUIDE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes outer sleeve is used with the PHILOS aiming device to help a surgeon line up and lock the surgical trajectory. The 57 reports mostly describe sleeves and drill guides that do not fit together properly — parts sticking, twisting or bending, and sleeves so tight they would not slide or come apart even with lubricant. No deaths or injuries were reported, and there are no recalls.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10886982074850), received between Dec 11, 2018 and Mar 31, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (48 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility48
- Material Deformation9
- Material Twisted/Bent4
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Consequences Or Impact To Patient10
- No Code Available3
- Not Applicable2
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Device-Device Incompatibility
IT WAS REPORTED THE DRILL SLEEVES WERE DIFFICULT TO CONNECT. IT WAS NOTED THEY CAN ONLY BE PLUGGED TOGETHER WITH GREAT FORCE. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746573 ↗MalfunctionJan 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE SLEEVES DO NOT SLIDE FREELY EVEN WITH LUBRICATION AND NEED TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995752 ↗MalfunctionJan 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE SLEEVES DO NOT SLIDE FREELY EVEN WITH LUBRICATION AND NEED TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995748 ↗MalfunctionJan 6, 2026Device-Device Incompatibility
IT WAS REPORTED ON AN (B)(6) 2025, THE SLEEVES DID NOT SLIDE FREELY EVEN WITH LUBRICATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980676 ↗MalfunctionJan 6, 2026Device-Device Incompatibility
IT WAS REPORTED ON AN (B)(6) 2025, THE SLEEVES DID NOT SLIDE FREELY EVEN WITH LUBRICATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980271 ↗MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BOTH PHILOS DRILL SLEEVES 5.0/2.9 ARE EXTREMELY HARD TO REMOVE FROM THE OUTER SLEEVES 6.0/5.0. NO PATIENT INVOLVEMENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717357 ↗MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BOTH PHILOS DRILL SLEEVES 5.0/2.9 ARE EXTREMELY HARD TO REMOVE FROM THE OUTER SLEEVES 6.0/5.0. NO PATIENT INVOLVEMENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717221 ↗MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PHILOS AIMING DEVICE SLEEVES WERE NOT FITTING TOGETHER CORRECTLY WITH EACH OTHER OR AIMING DEVICE. DRILL SLEEVE IS TOO TIGHT IN OUTER SLEEVE TO BE USED CORRECTLY, AND OUTER SLEEVE TO LOSE IN AIMING DEVICE TO CORRECTLY TARGET LOCKING TRAJECTORY. THIS HAS COMPLAINT HAS NOW BEEN REPORTED IN MULTIPLE LOCAL SITES (DIFFERENT SURGEONS) ALL WITH THE SAME PROBLEMS, WITH THE SAME PRODUCT CODES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4). THIS REPORT IS TO CAPTURE THE ALLEGATION THAT THIS ISSUE HAS OCCURRED ON PREVIOUS OCCASIONS/LOCATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003134 ↗MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PHILOS AIMING DEVICE SLEEVES WERE NOT FITTING TOGETHER CORRECTLY WITH EACH OTHER OR AIMING DEVICE. DRILL SLEEVE IS TOO TIGHT IN OUTER SLEEVE TO BE USED CORRECTLY, AND OUTER SLEEVE TO LOSE IN AIMING DEVICE TO CORRECTLY TARGET LOCKING TRAJECTORY. THIS HAS COMPLAINT HAS NOW BEEN REPORTED IN MULTIPLE LOCAL SITES (DIFFERENT SURGEONS) ALL WITH THE SAME PROBLEMS, WITH THE SAME PRODUCT CODES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4). THIS REPORT IS TO CAPTURE THE ALLEGATION THAT THIS ISSUE HAS OCCURRED ON PREVIOUS OCCASIONS/LOCATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003129 ↗MalfunctionSep 5, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PHILOS AIMING DEVICE SLEEVES WERE NOT FITTING TOGETHER CORRECTLY WITH EACH OTHER OR AIMING DEVICE. DRILL SLEEVE TOO TIGHT IN OUTER SLEEVE TO BE USED CORRECTLY, AND OUTER SLEEVE TO LOSE IN AIMING DEVICE TO CORRECTLY TARGET LOCKING TRAJECTORY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22984281 ↗MalfunctionSep 5, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PHILOS AIMING DEVICE SLEEVES WERE NOT FITTING TOGETHER CORRECTLY WITH EACH OTHER OR AIMING DEVICE. DRILL SLEEVE TOO TIGHT IN OUTER SLEEVE TO BE USED CORRECTLY, AND OUTER SLEEVE TO LOSE IN AIMING DEVICE TO CORRECTLY TARGET LOCKING TRAJECTORY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22984271 ↗MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE, PHILOS AIMING DEVICE SLEEVES WERE NOT FITTING TOGETHER CORRECTLY WITH EACH OTHER OR THE AIMING DEVICE. THE DRILL SLEEVE WAS TOO TIGHT IN THE OUTER SLEEVE TO BE USED CORRECTLY, AND THE OUTER SLEEVE TO LOOSE IN THE AIMING DEVICE TO CORRECTLY TARGET LOCKING TRAJECTORY. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645064 ↗MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE, PHILOS AIMING DEVICE SLEEVES WERE NOT FITTING TOGETHER CORRECTLY WITH EACH OTHER OR THE AIMING DEVICE. THE DRILL SLEEVE WAS TOO TIGHT IN THE OUTER SLEEVE TO BE USED CORRECTLY, AND THE OUTER SLEEVE TO LOOSE IN THE AIMING DEVICE TO CORRECTLY TARGET LOCKING TRAJECTORY. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645046 ↗MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE DAMAGED. ISSUE WAS NOTED POSTOPERATIVELY. THE PATIENT WAS NOT AFFECTED. THE MOST DISTAL PART OF THE PRODUCT IS TOO TIGHT AND WON'T ALLOW FOR THE DRILL SLEEVE TO BE REMOVED; THE AIMING DEVICE REQUIRES SIGNIFICANT FORCE TO BE REMOVED. IT WAS NOTED THAT THIS ISSUE HAS BEEN CAUSING DELAYS IN CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420111 ↗MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE DAMAGED. ISSUE WAS NOTED POSTOPERATIVELY. THE PATIENT WAS NOT AFFECTED. THE MOST DISTAL PART OF THE PRODUCT IS TOO TIGHT AND WON'T ALLOW FOR THE DRILL SLEEVE TO BE REMOVED; THE AIMING DEVICE REQUIRES SIGNIFICANT FORCE TO BE REMOVED. IT WAS NOTED THAT THIS ISSUE HAS BEEN CAUSING DELAYS IN CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420107 ↗MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE DAMAGED. ISSUE WAS NOTED POSTOPERATIVELY. THE PATIENT WAS NOT AFFECTED. THE MOST DISTAL PART OF THE PRODUCT IS TOO TIGHT AND WON'T ALLOW FOR THE DRILL SLEEVE TO BE REMOVED; THE AIMING DEVICE REQUIRES SIGNIFICANT FORCE TO BE REMOVED. IT WAS NOTED THAT THIS ISSUE HAS BEEN CAUSING DELAYS IN CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420106 ↗MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE DAMAGED. ISSUE WAS NOTED POSTOPERATIVELY. THE PATIENT WAS NOT AFFECTED. THE MOST DISTAL PART OF THE PRODUCT IS TOO TIGHT AND WON'T ALLOW FOR THE DRILL SLEEVE TO BE REMOVED; THE AIMING DEVICE REQUIRES SIGNIFICANT FORCE TO BE REMOVED. IT WAS NOTED THAT THIS ISSUE HAS BEEN CAUSING DELAYS IN CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420104 ↗MalfunctionSep 26, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE LOAN SET INSTRUMENT HAD A DAMAGED TIP, SO THE INNER TUBE WOULDN'T PUSH THROUGH. THIS DIDN'T CAUSE ANY ISSUES WITH THE PATIENT OR DELAYS TO THE SURGERY AS THERE WERE THREE ON THE SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309996 ↗MalfunctionMay 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 IT WAS NOTICED POST-OPERATIVELY THAT THREE (3) OUTER SLEEVES WERE JAMMING WHEN THEY ARE INSERTED INTO THE PHILOS PLATE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) OUTER SLEEVE FOR INSERTION GUIDE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282164 ↗MalfunctionMay 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 IT WAS NOTICED POST-OPERATIVELY THAT THREE (3) OUTER SLEEVES WERE JAMMING WHEN THEY ARE INSERTED INTO THE PHILOS PLATE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) OUTER SLEEVE FOR INSERTION GUIDE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282158 ↗MalfunctionMay 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 IT WAS NOTICED POST-OPERATIVELY THAT THREE (3) OUTER SLEEVES WERE JAMMING WHEN THEY ARE INSERTED INTO THE PHILOS PLATE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) OUTER SLEEVE FOR INSERTION GUIDE THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282148 ↗MalfunctionNov 3, 2023Material Deformation; Material Deformation
MalfunctionMay 1, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CONSULTANT WAS USING THIS INSTRUMENT DURING A CASE AND HE COULD NOT PUT THE OUTER SLEEVE AND DRILL SLEEVE TOGETHER, SO HE HAD TO OPEN A NEW TRAY, AS THE OUTER SLEEVE IS DAMAGED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) OUTER SLEEVE FOR INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16842886 ↗MalfunctionApr 17, 2023Material Deformation; Material Deformation
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PRODUCT WAS BENT AT THE TIP. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) OUTER SLEEVE FOR INSERTION GUIDE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750795 ↗MalfunctionApr 17, 2023Material Deformation; Material Deformation
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PRODUCT WAS BENT AT THE TIP. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) OUTER SLEEVE FOR INSERTION GUIDE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750794 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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