MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL TARGETING ARM GAMMA4; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
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: "when the surgeon attempted to implant the distal locking screw, the surgeon hit the nail with the drill going through the triple trocars on gamma4 system.".
Event or Problem Description
As reported: "when the surgeon attempted to implant the distal locking screw, the surgeon hit the nail with the drill going through the triple trocars on gamma4 system.".
Additional Manufacturer Narrative
The reported event of alleged guidance inaccuracy could not be confirmed, since the returned device is conforming to specifications and fully functional.As the nail was implanted and the surgical procedure successfully completed, this could be interpreted as an indication that no discrepancy with the nail used was suspected.Potentially reduced accuracy in guidance is usually found during functional check [required per ifu].In case of any deviation, it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.Finally, based on above and referring to the fact that nothing was reported at the time of pre-functional check, which is required before surgery, it could not be excluded that the case is rather related to sub-optimal intraoperative procedure.However, a check in combination with used nail and used sleeve assembly [tissue protection sleeve and locking drill sleeve] was impossible since only the proximal targeting arm gamma4 and targeting sleeve gamma 4 + targeting sleeve knob were made available, and the nail is still implanted.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: PROXIMAL TARGETING ARM GAMMA4
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20679676
• Report Number: 0009610622-2024-00913
• Device Sequence Number: 12622654
• Product Code: HSB
• UDI-Device Identifier: 07613327479904
• UDI-Public: 07613327479904
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• 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): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14200100
• Device Lot Number: RA974002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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
• Patient Sex: Unknown