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

Catalog Number	13200111
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : hospital retained.
Event or Problem Description
As reported: "c-ring in 1320-0111 detached during surgery.No replacement device used:".
Event or Problem Description
As reported: "c-ring in 1320-0111 detached during surgery.No replacement device used:".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matched the alleged issue.The device inspection revealed the following: the received target device overall appeared to be in good shape with normal signs of usage and no visible damage.However, the c-ring at the proximal end was found to be slightly disfigured and was having a greater gap with the metal tube.The c-ring could be detached with minimal force which is not desirable.The c-ring had deformed which confirms that it was mishandled during use and/or during reprocessing.A pre-surgical functional test was performed by attaching a nail to the target device to check the clamping function of the c-ring.It was found that the nail could still be held by the target device and that the functionality was still given.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.Based on the above investigation, the root cause of the issue is deemed to be user related.The deformation of the c-ring clearly indicates towards a mishandling at the user end.Mostly likely the c-ring was forcibly removed for reasons unknown.The c-ring is not designed to be detachable.If it is done, it is considered as an off-label use.In no case, the ring shall be detached, not even for cleaning purposes.If any further information is provided, the complaint report will be updated.

• 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: 18278430
• Report Number: 0009610622-2023-00440
• Device Sequence Number: 6263793
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/21/2024

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: 13200111
• Device Lot Number: KME911497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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: Required Intervention
• Patient Sex: Unknown