PROFYLERecalls & reported problems across all models
Stryker GmbH · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 21 models of PROFYLE by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jul 16, 2018 and Sep 15, 2025 — classified as 12 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PROFYLE problems
Device problems
- Fracture14
- Break10
- Use of Device Problem3
- Device Dislodged or Dislocated2
- Component Missing1
- Defective Device1
- Incorrect Measurement1
- Mechanical Problem1
Patient problems
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient4
- Device Embedded In Tissue or Plaque3
- Implant Pain3
- Perforation3
- Injury2
PROFYLE models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROFYLE 60-14326BIT, DRILL3 reports
- PROFYLE 60-25126BIT, DRILL3 reports
- PROFYLE 57-05170PLATE, FIXATION, BONE1 report
- PROFYLE 57-05240PLATE, FIXATION, BONE1 report
- PROFYLE 57-10191PLATE, FIXATION, BONE1 report
- PROFYLE 57-13110PLATE, FIXATION, BONE1 report
- PROFYLE 57-13150PLATE, FIXATION, BONE1 report
- PROFYLE 60-10115BIT, DRILL1 report
- PROFYLE 60-14126BIT, DRILL1 report
- PROFYLE 60-19126BIT, DRILL1 report
- PROFYLE 60-19426BIT, DRILL1 report
- PROFYLE 60-20385BIT, DRILL1 report
- PROFYLE 62-10110ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- PROFYLE 60-19340Plate, fixation, bone1 report
- PROFYLE 60-88117BIT, DRILL1 report
- PROFYLE 57-10470PLATE, FIXATION, BONE1 report
- PROFYLE 59-23010PLATE, FIXATION, BONE1 report
- PROFYLE 59-23012PLATE, FIXATION, BONE1 report
- PROFYLE 59-23013PLATE, FIXATION, BONE1 report
- PROFYLE 59-23014PLATE, FIXATION, BONE1 report
- PROFYLE 59-23022PLATE, FIXATION, BONE1 report
Recent PROFYLE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Break; Fracture; Break; Fracture
AS REPORTED: "AN ELECTRIC MOTOR TEST WAS PERFORMED. THE DRILL WAS HANDED TO THE SURGEON TO BEGIN BONE DRILLING, DURING WHICH THE DRILL BIT BROKE, LEAVING A FRAGMENT INSIDE. THE SPECIALIST DID NOT REMOVE IT DUE TO THE DIFFICULTY OF EXTRACTION. THE OSTEOSYNTHESIS PROCEDURE CONTINUED USING A NEW DRILL BIT."
Patient problems: Foreign Body In Patient
MAUDE report 23053302 ↗MalfunctionDec 4, 2023Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED: "PATIENT OPERATED ON 04/10/2023 FOR OSTEOSYNTHESIS OF METACARPUS D3 AND D4. DURING BONE DRILLING IN PREPARATION FOR SCREW INSERTION OF A SCREW, THE ANCILLARY DRILL BIT BROKE OFF FLUSH WITH THE BONE, PREVENTING ANY ATTEMPT TO EXTRACT THE DRILL BIT WITHOUT BEING MORE DELETERIOUS. THE SURGEON DECIDED TO LEAVE THE DRILL BIT IN THE METATARSAL".
Patient problems: Foreign Body In Patient
MAUDE report 18263112 ↗MalfunctionApr 4, 2023Break; Fracture; Break; Fracture
AS REPORTED: THE DRILL TIP BROKE OFF INTRAOPERATIVELY. ALL THE DEBRIS WERE REMOVED FROM THE SURGICAL FIELD/PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16678189 ↗InjuryDec 13, 2022Break; Fracture; Break; Fracture
AS REPORTED: "ON (B)(6) 2021, THE PATIENT CAME TO OUR HOSPITAL FOR INTERNAL FIXATION OF THE FRACTURE DUE TO THE FIRST METATARSAL FRACTURE OF THE LEFT FOOT. AFTER THAT, THE PATIENT RECOVERED WELL. ON (B)(6) 2022, THE PATIENT'S X-RAY REEXAMINATION SHOWED THAT THE SCREW WAS BROKEN, AND THE PATIENT HAD NO OBVIOUS DISCOMFORT. ON (B)(6) 2022, A SURGERY WAS PERFORMED TO TAKE THE SCREW OUT, BUT THE BROKEN SCREW COULD NOT BE REMOVED AND RETAINED IN THE BONE."
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 15965862 ↗InjuryDec 1, 2022Break; Fracture; Break; Fracture
AS REPORTED: "ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF PAIN AND POOR ACTIVITY IN THE RIGHT FOOT DUE TO FALLING DOWN. IT WAS CONFIRMED THAT 2 AND 4 METATARSAL OF THE RIGHT FOOT OF THE PATIENT FRACTURED. THEN SURGERY WAS PERFORMED TO THE PATIENT. AFTER THE SURGERY, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WENT TO THE HOSPITAL FOR EXAMINATION REGULARLY . ON (B)(6) 2022, THE PATIENT CAME TO THE HOSPITAL TO REMOVE THE STEEL PLATE. THE PREOPERATIVE RADIOGRAPH SHOWED THAT THE STEEL PLATE WAS BROKEN, AND THE PATIENT DID NOT COMPLAIN ANY OBVIOUS DISCOMFORT. THE DOCTOR THOUGHT THAT THE BONE HEALED WELL AFTER EXAMINATION, AND AGREED TO REMOVE THE PLATE. THE PATIENT IS IN GOOD CONDITION AFTER THE SURGERY OF REMOVAL OF THE PLATE. THE EVENT DID NOT CAUSE HARM TO THE PATIENT."
Patient problems: Failure of Implant
MAUDE report 15900416 ↗InjuryNov 21, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT "TOO FAST THREADED DRILL (SECOND DEVICE), FOR WHICH THE SURGEON PIERCED THE FINGER OF THE PATIENT. INJURIES REQUIRING HEALING CARE."
Patient problems: Perforation
MAUDE report 15840844 ↗InjuryNov 21, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT "TOO FAST THREADED DRILL (SECOND DEVICE), FOR WHICH THE SURGEON PIERCED THE FINGER OF THE PATIENT. INJURIES REQUIRING HEALING CARE."
Patient problems: Perforation
MAUDE report 15840698 ↗InjuryNov 18, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT "TOO FAST THREADED DRILL (SECOND DEVICE), FOR WHICH THE SURGEON PIERCED THE FINGER OF THE PATIENT. INJURIES REQUIRING HEALING CARE."
Patient problems: Perforation
MAUDE report 15829361 ↗MalfunctionNov 18, 2022Off-Label Use; Off-Label Use
AS REPORTED: "A PATIENT HAS HAD A NON STERILE FINGER PLATE FROM THE VARIAX 2 HAND PLATING SYSTEM IMPLANTED. THIS WAS IDENTIFIED BY THE HOSPITAL NURSE WHEN SHE LOOKED AT THE DEVICE PACKAGING FOLLOWING THE OPERATION". IT WAS AN OPEN REDUCTION AND INTERNAL FIXATION OF A FINGER FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15825720 ↗InjuryJul 11, 2022Break; Fracture; Break; Fracture
ON (B)(6) 2022 THE DOCTOR REPORTED AN ADVERSE EVENT FOR A PATIENT THAT HAD BEEN OPERATED ON, ON (B)(6) 2022. HE EXPRESSES THAT THE MATERIAL SUFFERED FATIGUE AND SO THE IMPLANT HAD TO BE REMOVED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture
MAUDE report 14982721 ↗MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture
"PER THE CUSTOMER, DRILL BIT BROKE DURING PROCEDURE. PIECE OF DRILL BIT WAS UNABLE TO BE RETRIEVED IN BONE PER SURGEON." PROCEDURE WAS AN ORIF OF FINGER.
Patient problems: Foreign Body In Patient
MAUDE report 13553066 ↗InjuryDec 16, 2021Break; Fracture; Break; Fracture
AS REPORTED: "ON (B)(6)2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FRACTURE OF THE FIRST TOE BONE. ON (B)(6),2020, THE PATIENT WAS TREATED WITH PLATE COMBINED WITH KIRSCHNER WIRE INTERNAL FIXATION, AND WAS DISCHARGED AFTER IMPROVEMENT. THE DOCTOR ORDERED REGULAR REVIEW IN THE OUTPATIENT DEPARTMENT. ON (B)(6) 2021, THE PATIENT CAME TO THE OUTPATIENT DEPARTMENT OF OUR HOSPITAL DUE TO THE DISCOMFORT OF THE SURGICAL SITE. THE FILM SHOWED THAT THE PLATE WAS BROKEN, AND HE WAS HOSPITALIZED IMMEDIATELY. ON (B)(6), INTERNAL FIXATION WAS REMOVED AND KIRSCHNER WIRE WAS USED FOR INTERNAL FIXATION. POSTOPERATIVE CONDITION IS STABLE. THE INCIDENT LED TO A SECOND OPERATION."
Patient problems: Failure of Implant; Implant Pain
MAUDE report 13018917 ↗InjuryNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED: "ON (B)(6), 2015. THE PATIENT'S LEFT HAND WAS INJURED BY A MACHINE ACCIDENTALLY AT HOME. FINALLY, DOCTOR DIAGNOSED THAT PATIENT¿S LEFT THUMB AND INDEX FINGER WERE NOT COMPLETELY SEVERED. ON (B)(6), 2015 , LEFT HAND DEBRIDEMENT, THUMB REPLANTATION, MIDDLE FINGER EXTENSOR TENDON REPAIR, BACK OF HAND AVULSION SKIN REPAIR, FOREIGN BODY REMOVAL, VSD DRAINAGE. THE MEDICAL OPERATION WAS SUCCESSFULLY. RECENTLY, THE PATIENT HAD LOCAL PROTRUSION OF THE PROXIMAL SEGMENT OF THE INDEX FINGER WITH SWELLING AND PAIN FOR MORE THAN 20 DAYS. ON (B)(6) 2021, PATIENT PERFORMED X RAY. THE IMAGE SHOW THAT PROXIMAL INDEX FINGER WAS FIXED WITH PLATE SCREWS AFTER MULTIPLE FRACTURES OF THE LEFT HAND. B ULTRASONOGRAPHY: SCREW ECHO IN THE PROXIMAL RADIAL SEGMENT OF THE LEFT INDEX FINGER. A PLATE SCREW INTERNAL FIXATION WAS PERFORMED TO REMOVE A BONE SCREW AND A PLATE." ADDITIONAL INFORMATION RECEIVED - (B)(6)/2021 THE PATIENT WENT TO THE DOCTOR AGAIN ON (B)(6), 2021 DUE TO LOCAL PROTRUSION AND REDNESS OF THE PROXIMAL INDEX FINGER. THE PATIENT HAS PERFORMED REVISION SURGERY, THE PLATE HAD BEEN REMOVED FROM PATIENT AND SCRAPPED BY HOSPITAL AS MEDICAL WASTE. ACCORDING TO THE DOCTOR'S PHYSICAL EX
Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema
MAUDE report 12867704 ↗InjuryNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED: "ON (B)(6), 2015. THE PATIENT'S LEFT HAND WAS INJURED BY A MACHINE ACCIDENTALLY AT HOME. FINALLY, DOCTOR DIAGNOSED THAT PATIENT¿S LEFT THUMB AND INDEX FINGER WERE NOT COMPLETELY SEVERED. ON (B)(6), 2015 , LEFT HAND DEBRIDEMENT, THUMB REPLANTATION, MIDDLE FINGER EXTENSOR TENDON REPAIR, BACK OF HAND AVULSION SKIN REPAIR, FOREIGN BODY REMOVAL, VSD DRAINAGE. THE MEDICAL OPERATION WAS SUCCESSFULLY. RECENTLY, THE PATIENT HAD LOCAL PROTRUSION OF THE PROXIMAL SEGMENT OF THE INDEX FINGER WITH SWELLING AND PAIN FOR MORE THAN 20 DAYS. ON (B)(6) 2021, PATIENT PERFORMED X RAY. THE IMAGE SHOW THAT PROXIMAL INDEX FINGER WAS FIXED WITH PLATE SCREWS AFTER MULTIPLE FRACTURES OF THE LEFT HAND. B ULTRASONOGRAPHY: SCREW ECHO IN THE PROXIMAL RADIAL SEGMENT OF THE LEFT INDEX FINGER. A PLATE SCREW INTERNAL FIXATION WAS PERFORMED TO REMOVE A BONE SCREW AND A PLATE." ADDITIONAL INFORMATION RECEIVED - (B)(6) 2021 THE PATIENT WENT TO THE DOCTOR AGAIN ON (B)(6) 2021 DUE TO LOCAL PROTRUSION AND REDNESS OF THE PROXIMAL INDEX FINGER. THE PATIENT HAS PERFORMED REVISION SURGERY, THE PLATE HAD BEEN REMOVED FROM PATIENT AND SCRAPPED BY HOSPITAL AS MEDICAL WASTE. ACCORDING TO THE DOCTOR'S PHYSICAL EXA
Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema
MAUDE report 12867604 ↗MalfunctionMay 4, 2021Fracture; Fracture
THE CUSTOMER REPORTED: "THE DRILL BIT BROKE OFF IN THE PATIENT'S BONE DURING USE. THE SURGEON WAS UNABLE TO REMOVE IT."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11771737 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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