MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM; PLATE, FIXATION, BONE

Model Number	627233S
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported the holes for k-wire/suture on a stryker proximal humerus plate have a fiber wire torn/snapped.The device was implanted on tubercle minus to fix/fixate on the proximal humerus.The issue was observed during a revision surgery performed on (b)(6) 2021.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported the holes for k-wire/suture on a stryker proximal humerus plate have a fiber wire torn/snapped.The device was implanted on tubercle minus to fix/fixate on the proximal humerus.The issue was observed during a revision surgery performed on (b)(6) 2021.The revision surgery was performed because during the primary operation the reposition of the fragments needed to be done again.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM
• 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12377684
• Report Number: 0008031020-2021-00386
• Device Sequence Number: 4090668
• Product Code: HRS
• UDI-Device Identifier: 07613327091243
• UDI-Public: 07613327091243
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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 Expiration Date: 05/31/2025
• Device Model Number: 627233S
• Device Catalogue Number: 627233S
• Device Lot Number: G26481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• 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