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	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the surgeon missed with intermediate targeting sleeve for a gamma 4 intermediate nail.The alpha 4.2x360mm drill hit the nail and would not pass through the dynamic hole.As the surgeon gradually tried to find his position the drill skived posterior to the nail.In the ap it appeared to have made it through the hole.On the lateral the screw was posterior.The surgeon locked proximally to the dynamic hole using the intermediate targeting sleeve and passed through the nail without any issues.We locked the proximal static hole and left the distal dynamic hole open.".
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 on a supplemental report.

• 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: 20441027
• Report Number: 0009610622-2024-00862
• Device Sequence Number: 8275892
• Product Code: HSB
• UDI-Device Identifier: 07613327479904
• UDI-Public: 07613327479904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: 14200100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/14/2024
• 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
• Patient Sex: Unknown