MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM; APPLIANCE,FIXATION,NAIL

Model Number	292.71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional pro-code - jey.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, during a removal of k wire from a bone due to a temporary fixation, the wire broke and part of it was left in tibia.There was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unknown extraction instrument (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) devices.This report is 1 of 1 for pc-(b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9614267
• Report Number: 2939274-2020-00310
• Device Sequence Number: 10893683
• Product Code: KTT
• UDI-Device Identifier: 20886982180862
• UDI-Public: (01)20886982180862
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K971987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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: Health Professional
• Device Model Number: 292.71
• Device Catalogue Number: 292.71
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR