MAUDE Adverse Event Report: STRYKER GMBH AIMING BLOCK AXSOS 3 TI PROX. LAT. HUMERUS, RIGHT; PLATE, FIXATION, BONE

Catalog Number	705069
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during surgery for a fracture of the humerus using our axsos 3 system, the screw of the 705063 targeting block broke and remained in the definitive implant.".
Event or Problem Description
As reported: "during surgery for a fracture of the humerus using our axsos 3 system, the screw of the 705063 targeting block broke and remained in the definitive implant.".
Additional Manufacturer Narrative
Corrections: d1, d4 (catalog number and gtin) and d9 the device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.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.More information as well as the affected device must be available in order to determine the root cause of the issue.The ifu instructs the user that: ¿while rare, intra-operative fracture or breakage of instruments can occur.Instruments which have experienced excessive use or excessive force are susceptible to fracture.Instruments should be examined for wear or damage prior to surgery.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AIMING BLOCK AXSOS 3 TI PROX. LAT. HUMERUS, RIGHT
• 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: 19084506
• Report Number: 0008031020-2024-00161
• Device Sequence Number: 7722271
• Product Code: HRS
• UDI-Device Identifier: 07613327073065
• UDI-Public: 07613327073065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Catalogue Number: 705069
• Device Lot Number: V37268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female