MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH; INSTRUMENT COMPRESSION

Catalog Number	03.211.415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.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 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 event occurred on (b)(6) 2018, during charcot midfoot fusion.While applying the compression layer, the surgeon went too far when using the compression wire and the thread snapped off.Another wire was used to complete the surgery.There was a 2-minute surgical delay reported.The procedure was completed successfully.This report is for one (1) 1.6mm compression wire 15mm thread/150mm length.This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM COMPRESSION WIRE 15MM 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: 8121120
• Report Number: 2939274-2018-55205
• Device Sequence Number: 11183105
• Product Code: HWN
• UDI-Device Identifier: 10886982076304
• UDI-Public: (01)10886982076304
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 11/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.211.415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/30/2018
• Patient Sequence Number: 1