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

Catalog Number	49331002
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a couple of proximal pins in the tibia in an lrf case were loose." also reported: "the revision was done due to loosening of the thin wires.The wires that appeared loose were replaced by half pins, which became stable.".
Additional Manufacturer Narrative
The reported event of 'component loosened' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by an inadequate handling of the device.The material certificate and the hardness test were reviewed.The material (washer's part) passed all the tests and it is conforming to stryker's specifications.Therefore, the failure was most probably caused by an inadequate handling.Most likely, a large force was applied leading to the damage of the device.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "a couple of proximal pins in the tibia in an lrf case were loose." also reported: "the revision was done due to loosening of the thin wires.The wires that appeared loose were replaced by half pins, which became stable.".

• Brand Name: WIRE BOLT - MEDIUM 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 ; CH 2545
• MDR Report Key: 9156818
• Report Number: 0008031020-2019-01355
• Device Sequence Number: 2589464
• Product Code: KTT
• UDI-Device Identifier: 07613252507796
• UDI-Public: 07613252507796
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K113327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 49331002
• Device Lot Number: D32614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention