MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 1.1MM THREADED GUIDE WIRE 150MM

Catalog Number	292.622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.This report is for a radial head - unknown lot.Device is an instrument and is not implanted/explanted.Complainant part has not been 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 during a surgery on (b)(6) 2017, the threaded tip of a guide pin broke off in a patient.It was further explained that while the surgeon was placing the guide pin for a 2.4 headless compression screw, the tip of the threaded tip broke off.The broken fragment was retrieved using an unknown instrument; the fragment was grabbed and easily removed.There was a ten-minute delay due to the retrieval of the fragment.There was no additional medical intervention required and the surgery was successfully completed with no harm to the patient.The patient was reported to be stable at the end of the procedure.The complained device was discarded and not available for investigation.All available information has been reported.This complaint involves one (1) device.This report is for a guide pin.(b)(4).

• Brand Name: 1.1MM 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: 7176016
• Report Number: 2939274-2018-50136
• Device Sequence Number: 11209137
• Product Code: FZX
• UDI-Device Identifier: 10886982180728
• UDI-Public: (01)10886982180728(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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 Catalogue Number: 292.622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR