MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM; MISC ORTHO SURGICAL INSTR

Catalog Number	02.111.501.10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.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 manufacture date is unknown.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 the tip of guide wire broke off during a right orif distal surgery.The broke piece was retrieved and outcome was not affected.Concomitant device report: [unknown wire driver] (part #: unknown, lot #: unknown, quantity: 1) and [2.4mm va-lcp 2-clmn vlr dstl radius pl 6h hd/3h shaft/right] (part #: 02.111.630, lot #: unknown, quantity: 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.

• Brand Name: 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7072474
• Report Number: 2939274-2017-50091
• Device Sequence Number: 1079791
• Product Code: LXH
• UDI-Device Identifier: 20886982031706
• UDI-Public: (01)20886982031706(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: 02.111.501.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1