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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A patient had an lrf frame on and 7 of their wires ended up breaking.We replaced all of the wires and added half pins as well.
Additional Manufacturer Narrative
Only 2 small pieces of wires were returned.These returned pieces were cut at the edge of the wire bolt by surgeon therefore, we have no surface of breakage to analyze.Further inspection is impossible with returned pieces.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A patient had an lrf frame on and 7 of their wires ended up breaking.We replaced all of the wires and added half pins as well.

• 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: 7567130
• Report Number: 0008031020-2018-00417
• Device Sequence Number: 19461628
• Product Code: KTT
• UDI-Device Identifier: 07613252610243
• UDI-Public: 07613252610243
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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 Catalogue Number: 49331002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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
• Patient Age: 60 YR