NA 03.133.081Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982269706), received between Dec 16, 2020 and Sep 17, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50812182 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THE DEPTH GAUGE BROKE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020979 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT POSTOPERATIVELY IT WAS IDENTIFIED THAT THE DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545575 ↗
• MalfunctionOct 20, 2025Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT DURING SMALL FRAGMENT ORIF PROCEDURES, IT WAS NOTED THAT ALL THE DEPTH GAUGES ON THE HOSPITAL'S USF¿S WERE FAILING. SURGEONS WERE STRUGGLING TO READ THE DEPTH GAUGES AND THE TIPS HAVE BEEN BROKEN OFF. SURGEONS WERE BECOMING FRUSTRATED WITH THE DEPTH GAUGES AND IT IS INCREASING OPERATION TIMES. FEEDBACK WAS THAT DEPTH GAUGES SHOULD BE LASTING LONGER THAN THEY CURRENTLY ARE. THERE HAS CURRENTLY BEEN NO IMPACT ON PATIENTS. NO SPECIFIC DATE HAS BEEN GIVEN FOR THIS, AS IT HAS BEGUN TO HAPPEN OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23340038 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT THE TIPS OF THE DEPTH GAUGES HAVE BROKEN OFF DURING SURGERY ON (B)(6) 2024. THE BROKEN TIPS WERE NOT REMAINED IN THE PATIENT. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 2.7/3.5MM DEPTH GAUGE 40 TO 100MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173503 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED INTRAOPERATIVELY ON JULY 29, 2024, THE TIP OF MULTIPLE DEPTH GAUGES ON MULTIPLE SETS BROKE OFF. NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY. THIS REPORT IS FOR ONE DEPTH GAUGE 2.7/3.5 40 - 100. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945094 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED INTRAOPERATIVELY ON (B)(6) 2024 THE TIP OF MULTIPLE DEPTH GAUGES ON MULTIPLE SETS BROKE OFF. NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY. THIS REPORT IS FOR ONE DEPTH GAUGE 2.7/3.5 40 - 100 THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944936 ↗
• MalfunctionMay 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED INTRA-OPERATIVELY, THE DEPTH GAUGE WAS DAMAGED; THE HOOK BENT. THERE WAS NO SURGICAL DELAY AS ANOTHER DEPTH GAUGE WAS AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS WAS REPORTED AS GOOD. THIS REPORT IS FOR A DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221540 ↗
• MalfunctionNov 21, 2023Incorrect Measurement; Device Slipped; Incorrect Measurement; Device Slipped

  IT WAS REPORTED DURING THE INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED. THERE SHOULD BE A RESISTANCE WHEN MOVING THE DEPTH GAUGE, SO THAT IT DOES NOT SLIP. THIS IS NOT THE CASE WITH THE PRODUCTS. THE LENGTH TO DETERMINE THE SCREWS CAN THEREFORE NOT BE CORRECT. THERE IS NO PATIENT IMPACT AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE DEPTH GAUGE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182866 ↗
• MalfunctionNov 21, 2023Incorrect Measurement; Device Slipped; Incorrect Measurement; Device Slipped

  IT WAS REPORTED DURING THE INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED. THERE SHOULD BE A RESISTANCE WHEN MOVING THE DEPTH GAUGE, SO THAT IT DOES NOT SLIP. THIS IS NOT THE CASE WITH THE PRODUCTS. THE LENGTH TO DETERMINE THE SCREWS CAN THEREFORE NOT BE CORRECT. THERE IS NO PATIENT IMPACT AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE DEPTH GAUGE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182584 ↗
• MalfunctionNov 21, 2023Incorrect Measurement; Device Slipped; Incorrect Measurement; Device Slipped

  IT WAS REPORTED DURING THE INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED. THERE SHOULD BE A RESISTANCE WHEN MOVING THE DEPTH GAUGE, SO THAT IT DOES NOT SLIP. THIS IS NOT THE CASE WITH THE PRODUCTS. THE LENGTH TO DETERMINE THE SCREWS CAN THEREFORE NOT BE CORRECT. THERE IS NO PATIENT IMPACT AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE DEPTH GAUGE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182376 ↗
• MalfunctionNov 21, 2023Incorrect Measurement; Device Slipped; Incorrect Measurement; Device Slipped

  IT WAS REPORTED DURING THE INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED. THERE SHOULD BE A RESISTANCE WHEN MOVING THE DEPTH GAUGE, SO THAT IT DOES NOT SLIP. THIS IS NOT THE CASE WITH THE PRODUCTS. THE LENGTH TO DETERMINE THE SCREWS CAN THEREFORE NOT BE CORRECT. THERE IS NO PATIENT IMPACT AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE DEPTH GAUGE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182268 ↗
• MalfunctionJul 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, THE STERILE PROCESSING DEPARTMENT NOTICED THAT THE DEPTH GAUGE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS DISCOVERED PREOPERATIVELY. THIS REPORT INVOLVES ONE 2.7/3.5MM DEPTH GAUGE 0 TO 60MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349181 ↗
• MalfunctionJun 1, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS, AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED, THAT ON AN UNKNOWN DATE, THE TIP OF THE 2.7/3.5 MM DEPTH GAUGE WAS BENT. THERE WERE NO PROBLEMS WITH THE REMAINING 6 PIECES IN THE LOT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE 2.7/3.5 40 - 100. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17041019 ↗
• MalfunctionFeb 6, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEPTH GAUGES IN QUESTION WERE FOUND TO BE BROKEN DURING STERILIZATION AND WERE REMOVED FROM THE TRAY. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THE ITEMS WERE FOUND POST-OP AND WERE IMMEDIATELY REMOVED FROM THE TRAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7/3.5MM DEPTH GAUGE 40 TO 100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308294 ↗
• MalfunctionDec 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DEVICE REPORT FROM GREAT BRITAIN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN OPERATOR RECEIVED A MINOR INJURY FROM THE DEPTH GAUGE IN QUESTION AS HE WAS PACKING THE ITEM TO BE SHIPPED. THE SHARP END OF THE DEPTH GAUGE HAD PENETRATED THE PLASTIC COVER/TUBE AND HAD CUT THE OPERATOR¿S RIGHT HAND. THIS EVENT DID NOT OCCUR IN A HOSPITAL AND DID NOT INVOLVE ANY SURGICAL PROCEDURES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7/3.5MM DEPTH GAUGE 40 TO 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 16052744 ↗
• MalfunctionDec 29, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGES TIP WAS FOUND TO BE BENT. THE ISSUE WAS IDENTIFIED WHEN THE ITEM WAS RECEIVED. THIS REPORT INVOLVES ONE (1) 2.7/3.5MM DEPTH GAUGE 40 TO 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114387 ↗
• MalfunctionFeb 1, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE KNITTING PROCESS OF A LOANER SET AT LOC UMKIRCH IT WAS NOTICED THAT DEPTH GAUGE WAS BENT. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.7/3.5MM DEPTH GAUGE 40 TO 100MM. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262942 ↗
• MalfunctionJan 29, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE CAME IN BROKEN. IT IS UNKNOWN HOW IT WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7/3.5MM DEPTH GAUGE 40 TO 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253114 ↗
• MalfunctionDec 16, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING KITTING OF A CONSIGNATION KIT, IT WAS NOTED THAT THE TIP OF THE DEPTH GAUGE IS BENT INSTEAD OF STRAIGHT. THERE WAS NO SURGERY IMPACT. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE DEPTH GAUGE 2.7/3.5 40-100. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019733 ↗