MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH; INSTRUMENT, COMPRESSION

Model Number	03.211.430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 history lot part: 03.211.430-us.Lot: 2l61889.Manufacturing site: (b)(4).Release to warehouse date: 18.Dec.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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) 2020, during insertion the compression wire broke off at the ball.Broken fragments were easily removed without additional intervention.There was a five (5) minute surgical delay.The procedure was successfully completed with another device.Patient outcome was unknown.This report is for one (1) 1.6mm compression wire 30mm thread/150mm length.This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9855564
• Report Number: 2939274-2020-01366
• Device Sequence Number: 11396436
• Product Code: HWN
• UDI-Device Identifier: 10886982076366
• UDI-Public: (01)10886982076366
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.211.430
• Device Catalogue Number: 03.211.430
• Device Lot Number: 2L61889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR