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

Catalog Number	13200111
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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: "distal locking of the gamma3 3125-1200s nail cannot be locked via target arm 1320-0111.Incorrect drilling occurs.Target device is "warped, misaligned".".
Event or Problem Description
As reported: "distal locking of the gamma3 3125-1200s nail cannot be locked via target arm 1320-0111.Incorrect drilling occurs.Target device is "warped/misaligned".".
Additional Manufacturer Narrative
The reported event could be confirmed, since the reported event of incorrect drilling during distal locking could not be confirmed.The device inspection revealed the following: the target device was returned for evaluation.The visual inspection has shown that the device is in a very used condition, the markings are faded, there are nicks, dents and scratches all over.There are marks from strong hammer blows all over the surface at the impactor interface and there are also dents at the inside of the impactor bore visible.There is crack visible at in the middle of the glass fiber reinforced arm at the crossover form the metal piece.A function test with a 200mm nail (same length as the reported catalog # 3125-1200s) was performed.All distal locking options, dynamic and static, were tested and no deviation could be detected, the drill bit did not touch the nail in any of the positions.The reported malfunction could not be reproduced.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.Visually is the returned target device in a end of life condition as it was obviously often and intense used since it was manufactured in the year 2013.Nevertheless, could the reported distal misdrilling not be confirmed during the performed evaluation, therefore the root cause was attributed to a user related issue.If more information is provided, the case will be reassessed.

• 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: 18713165
• Report Number: 0009610622-2024-00071
• Device Sequence Number: 15267797
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• 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: KME905736
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2013
• 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