MAUDE Adverse Event Report: STRYKER GMBH S PROFILE PLATE, T-SHAPE, 90 DEGREES, NARROW, 6 HOLES; PLATE, FIXATION, BONE

Model Number	57-05240S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
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.
Event or Problem Description
On 08-apr-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.
Additional Manufacturer Narrative
The reported event could be confirmed, since the broken plate is visible on the received x-rays.The affected device was not returned for evaluation, therefore no inspection was possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The complaint was forwarded to medical affairs for review with following feedback: "the x-ray shows a very unfavourable fracture at the transition from the middle to the distal third of the phalanx.The plate size (1,7mm) was chosen correctly and there are no obvious technical mistakes visible.However, due to the distinctly straight fracture line it came to a hypertrophic non-union and in the end failure of the plate.This failure can be seen as patient related due to the very unfavourable fracture pattern." based on investigation, the root cause was attributed to a patient related issue.The above described factors did finally lead to a fatigue failure of the plate.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: S PROFILE PLATE, T-SHAPE, 90 DEGREES, NARROW, 6 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14982721
• Report Number: 0008031020-2022-00329
• Device Sequence Number: 5099004
• Product Code: HRS
• UDI-Device Identifier: 04546540242587
• UDI-Public: 04546540242587
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 57-05240S
• Device Catalogue Number: 57-05240
• Device Lot Number: 1000367024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic