MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE,SURGICAL

Model Number	292.12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient information was available for reporting device is an instrument and is not implanted/explanted.Device is not available for evaluation.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.Reported on mw5075288.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Medwatch mw5075288.(b)(4).
Event or Problem Description
It was reported on maude report mw5075288 that a k wire broke intraoperatively while being inserted on (b)(6) 2018.The surgeon retrieved the fragments.No information is known on surgical delay or patient status.This is report 1 of 1 for (b)(4).

• Brand Name: NA
• 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: 7403783
• Report Number: 2939274-2018-51527
• Device Sequence Number: 680043
• Product Code: LRN
• UDI-Device Identifier: 20886982180343
• UDI-Public: (01)20886982180343(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 292.12
• Device Catalogue Number: 29212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1