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

Catalog Number	14200110
Medical Device Problem Codes	Failure to Align (2522); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient had a fractured proximal femur.The gamma 4 sleeve's button had popped out and was not locking in, and the intermediate sleeve was not aligning properly with the nail.A second set was opened to complete the surgery, adding 10-15 minutes to the procedure.A second set was used to complete the case and no issues were reported.
Event or Problem Description
It was reported that the patient had a fractured proximal femur.The gamma 4 sleeve's button had popped out and was not locking in, and the intermediate sleeve was not aligning properly with the nail.A second set was opened to complete the surgery, adding 10-15 minutes to the procedure.A second set was used to complete the case and no issues were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the affected device was not returned and the other evidence were not shared for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 exact root cause of the issue.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TARGETING SLEEVE 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: 19900736
• Report Number: 0009610622-2024-00728
• Device Sequence Number: 20453740
• Product Code: HSB
• UDI-Device Identifier: 07613327479911
• UDI-Public: 07613327479911
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 14200110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 69 YR
• Patient Sex: Female