MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 125 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.014

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Intraoperative event date unknown; date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.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 Description

It was reported that during a trochanteric fixation nail advanced (tfna) insertion on an unknown date, the tfna blade/screw guide sleeve was getting hung up on the aiming arm.A mallet was used to separate the guide sleeve from the aiming arm.The procedure was successfully completed with 10 minutes surgical delay.There was no patient consequence reported.Concomitant device reported: unknown tfna nail (part # unknown, lot # unknown, quantity 1), unknown buttress.Compression nut (part # unknown, lot # unknown, quantity 1).This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 Description

It was reported that on (b)(6) 2020 the trocar was jammed in the aiming arm and a mallet was used to free the trocar from aiming arm.Another aiming arm and trocar were used to complete the procedure.The patient status was good after procedure.

• Brand Name: 125 DEG AIMING ARM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10636287
• MDR Text Key: 210032621
• Report Number: 2939274-2020-04525
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070302
• UDI-Public: (01)10886982070302
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.014
• Device Catalogue Number: 03.037.014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIMING ARM LOCKING DEVICE; BLADE/SCREW GUIDE SLEEVE; UNK - NAILS: TFNA; UNK - NUTS; AIMING ARM LOCKING DEVICE; BLADE/SCREW GUIDE SLEEVE; UNK - NAILS: TFNA; UNK - NUTS