MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE, SURGICAL

Model Number	292.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.Device history review.
Event or Problem Description
It was reported that on (b)(6) 2019 during a fixation of a distal humerus fracture, a kirshner wire with trochar point broke inside the patient.The wire broke into two separate pieces and was left inside the distal humerus.The wire was not protruding from the bone and could not be extracted.There was no surgical delay and the procedure outcome was successful.No patient consequence.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8446012
• Report Number: 2939274-2019-57102
• Device Sequence Number: 344340
• Product Code: LRN
• UDI-Device Identifier: 20886982180374
• UDI-Public: (01)20886982180374
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAD
• 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): 02/27/2019

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 Model Number: 292.16
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/22/2019
• Patient Sequence Number: 1
• Patient Weight: 46