MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.013

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 sales consultant was performing a demo for the surgeon when it was noticed that the drill bit was hitting the nail on the distal locking screw on a short tfna.There was no patient involvement.Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity# 1).This report is for 1 130 deg aiming arm.This is report 2 of 4 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.Visual inspection: the 130 deg aiming arm (p/n: 03.037.013, lot number: l425624) was received at us cq.Visual inspection of the complaint device showed no damage or defects.Functional test: a functional assessment was unable to be performed on the complaint device since all the mating devices were not returned.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as a functional test could not be performed and there is no observed damage.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history part: 03.037.013, lot: l425624, manufacturing site: hägendorf, release to warehouse date: 22 sep 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• Brand Name: 130 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: 10225480
• MDR Text Key: 197382706
• Report Number: 2939274-2020-03071
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070296
• UDI-Public: (01)10886982070296
• 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: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.013
• Device Catalogue Number: 03.037.013
• Device Lot Number: L425624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPLETE RADIOLUCENT INSERTION HANDLE; UNK - DRILL BITS: TRAUMA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING; COMPLETE RADIOLUCENT INSERTION HANDLE; UNK - DRILL BITS: TRAUMA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING