MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM THREADED GUIDE WIRE 150MM

Catalog Number	900.722
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Device broke intra-operatively; device is no implanted or explanted.Reporter¿s first name and phone number is unknown.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.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) 2018, the tip of the threaded guide wire for cannulated screw broke off during open reduction internal fixation (orif) of the ankle and the guide wire left in the bone.There was patient consequence.There was no surgical delay reported.Patient outcome is unknown.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7829700
• Report Number: 2939274-2018-53538
• Device Sequence Number: 1287555
• Product Code: FZX
• UDI-Device Identifier: 10886982256331
• UDI-Public: (01)10886982256331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: Health Professional
• Device Catalogue Number: 900.722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention