MAUDE Adverse Event Report: STRYKER GMBH TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200111
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
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 by the rep: "the surgeon approached me following a short gamma3 nail.He was distally targeting the screws and aimed for the static hole but the screw was placed in the dynamic position and in his words appeared to catch on the edge of the hole.The procedure was completed successfully as the screw went into the dynamic hole position.".
Event or Problem Description
As reported by the rep: "the surgeon approached me following a short gamma3 nail.He was distally targeting the screws and aimed for the static hole but the screw was placed in the dynamic position and in his words appeared to catch on the edge of the hole.The procedure was completed successfully as the screw went into the dynamic hole position.".
Additional Manufacturer Narrative
Please note correction to section d9/h3 the device was lost by the customer.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was 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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.H3 other text : device lost by the customer.

• Brand Name: TARGET DEVICE GAMMA3®
• 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: 18623720
• Report Number: 0009610622-2024-00051
• Device Sequence Number: 2406477
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123401
• 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): 04/16/2024

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: 13200111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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