MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS; PLIERS, SURGICAL

Model Number 388.509

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is synthes sales consultant.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on an unknown date, the two (2) rod introduction pliers for dual-opening would not engage to hold the unknown collars when trying to load the instrument before starting a case.The collar kept falling off the persuader after trying to load it.The two technicians tried hard multiple times with multiple collars and were not successful in loading any collars to either of the persuaders.There was no patient involvement since it was discovered before starting the case.Concomitant medical products reported: unknown collars (part#: unknown, lot#: unknown, quantity#: unknown).This report is for one (1) rod introduction pliers for dual-opening impl.This is report 2 of 2 for (b)(4).

• Brand Name: ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8303146
• MDR Text Key: 135009763
• Report Number: 2939274-2019-56313
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10705034773339
• UDI-Public: (01)10705034773339
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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
• Device Operator: Health Professional
• Device Model Number: 388.509
• Device Catalogue Number: 388.509
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION