MAUDE Adverse Event Report: STRYKER GMBH WIRE BOLT - SHORT HOFFMANN LRF FOR WIRE Ø1.5 TO 2.0MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49331001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the investigation was carried out in collaboration with r&d mechanical engineering, you will find our explanation below: visual examination of the received products shows that three (3) of the received wire bolts were, that the deformation visible at the washer of the wire bolts are not quit strong as it should be (yellow marking), this is a clear indication that the wire bolt wasn¿t tightened enough.Furthermore, it is not possible to determine the exact position at which and where the parts were attached to the 3 wires.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 investigation, the root cause was attributed to a use related issue.The failure was caused most likely by to much force.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that there were 3 wire breakages.After conclusion of the investigation, it was noted that there was a clear indication that the wire bolt wasn¿t tightened enough.

• Brand Name: WIRE BOLT - SHORT HOFFMANN LRF FOR WIRE Ø1.5 TO 2.0MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19367322
• Report Number: 0008031020-2024-00223
• Device Sequence Number: 7703553
• Product Code: KTT
• UDI-Device Identifier: 07613252507789
• UDI-Public: 07613252507789
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113327
• 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
• Report Date (Section B): 05/21/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49331001
• Device Lot Number: AB4107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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