MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR ANTEGRADE STANDARD LOCKING; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.049
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review /investigation.Reporter is a sales consultant.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 on an unknown date, it was discovered in set audit that the faulty aiming arms for antegrade standard locking guide causing the drill to miss holes in the nail.It is unknown if procedure was successfully completed.There is no patient consequence.Concomitant devices reported: aiming arm for antegrade standard locking (part # 03.010.049, lot # unknown, quantity 2); standard insertion handle (03.010.045, lot # unknown, quantity 3); drill bit (part # unknown, lot # unknown, quantity 1); nail (part # unknown, lot # unknown, quantity 1).This report is for one (1) aiming arm for antegrade standard locking.This is report 3 of 8 for (b)(4).

• Brand Name: AIMING ARM FOR ANTEGRADE STANDARD LOCKING
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10488939
• Report Number: 2939274-2020-03961
• Device Sequence Number: 2676150
• Product Code: FZX
• UDI-Device Identifier: 10886982067210
• UDI-Public: (01)10886982067210
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/10/2020

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 Model Number: 03.010.049
• Device Catalogue Number: 03.010.049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1