MAUDE Adverse Event Report: STRYKER GMBH NAIL ADAPTER TIBIA SPI T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534113
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Difficult to Setup or Prepare (1487); 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
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported by rep: "strike plate snapped from the targeting adapter while inserting the nail (hitting the strike plate using the hammer)".
Event or Problem Description
As reported by rep: "strike plate snapped from the targeting adapter while inserting the nail (hitting the strike plate using the hammer)".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The returned targeting arm and strike plate were visually inspected where visible scratch and nick marks are on the device which indicate usage over some time.The broken threads of the strike plate are stuck inside a threaded hole meant for the strike plate in the nail adapter, after breaking.The broken thread portion of the strike plate was not returned.The broken surface of the thread indicates a sign of a brittle fracture evident by abrupt breakage no definite fracture progression lines on the fractured surface and no presence of plastic deformation as well.The strike plate may have been not seated flush with the target device and impacted in a non-axial direction.The assembly hole of the targeting arm is deformed which indicates the strike plate was hit from the side.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.Based on the investigation, the root cause was attributed to being user related.If any further information is provided, the complaint report will be updated.
Additional Manufacturer Narrative
Correction: please refer to h6 device code.
Event or Problem Description
As reported by rep: "strike plate snapped from the targeting adapter while inserting the nail (hitting the strike plate using the hammer)".

• Brand Name: NAIL ADAPTER TIBIA SPI T2 ALPHA? TIBIA
• 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: 18727661
• Report Number: 0009610622-2024-00073
• Device Sequence Number: 12143855
• Product Code: HSB
• UDI-Device Identifier: 07613327358018
• UDI-Public: 07613327358018
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193308
• 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,Followup
• Report Date (Section B): 06/21/2024

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: 23534113
• Device Lot Number: KME912192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 05/29/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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