MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 8 HOLE / L95MM; PLATE, FIXATION, BONE

Model Number	626678
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a variax plate was implanted on (b)(6) 2022.In mid-november 2022, patient noticed something was not right.On (b)(6) 2023, broken plate was removed.
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.
Additional Manufacturer Narrative
The reported event could be confirmed, since an x-ray was provided which confirms the post-op variax 2 plate breakage.The device was not returned due to hospital policy and due to that further inspection of the device was not possible.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.An x-ray was received and reviewed by the internal health care professional, during which it was surmised that the position of the plates in the lower part of the upper extremity may have played a role in in early failure however this cannot be concluded in certainty without the review of better-quality x-rays.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that a variax plate was implanted on (b)(6) 2022.In (b)(6) 2022, patient noticed something was not right.On (b)(6) 2023, broken plate was removed.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 8 HOLE / L95MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 16268648
• Report Number: 0008031020-2023-00037
• Device Sequence Number: 20451842
• Product Code: HRS
• UDI-Device Identifier: 07613327088823
• UDI-Public: 07613327088823
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: Lay User/Patient
• Device Model Number: 626678
• Device Catalogue Number: 626678
• Device Lot Number: K48385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: 73 YR
• Patient Sex: Female