MAUDE Adverse Event Report: STRYKER GMBH STANDARD BARREL HIP PLATE, KEYED OMEGA 3 130°, 12 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	597012S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a broken plate was found in the queensland kit room.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matched the alleged issue.The device inspection revealed the following: the received omega plate was found to be broken around the third hole from the proximal side.No significant evidence of any user induced damage could be observed apart from the usual explantation marks.The fracture surface was found to be relatively smooth and showed evidence of a fatigue fracture, originating from the lateral aspect of the plate, along the shorter side of the hole.Slight appearance of lines of rest was observed running from lateral to medial.The broader side of the hole showed a typical instantaneous fracture zone indicating the area of final detachment.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation it could be concluded that the plate broke in a fatigue manner.However, since exact details of the event, when it happened how long the plate was inside the patient, radiographs and other patient details were not available, a real root cause of the issue could not be determined.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that a broken plate was found in the queensland kit room.Update: it was confirmed by evaluation of the device that the device had been implanted and broke in the patient and was revised.

• Brand Name: STANDARD BARREL HIP PLATE, KEYED OMEGA 3 130°, 12 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17777823
• Report Number: 0008031020-2023-00338
• Device Sequence Number: 17826679
• Product Code: KTT
• UDI-Device Identifier: 07613154325054
• UDI-Public: 07613154325054
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 597012S
• Device Lot Number: Y22253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2018
• 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 Sex: Unknown