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 Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2019, during a routine inspection of consignment instrument sets, the rod introduction pliers for dual-opening implants ratchet came off and could not be put back onto the instrument.The two parts of the depth gauge for pedicle screws came apart and would not attach again.There was no patient involvement.This report is for one (1) rod introduction pliers for dual-opening impl f/6.0mm rods this is report 1 of 1 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.H10 additional narrative: d10: part returned (b)(6) 2019 - not the final destination.H3, h4, h6: device history lot, part number: 388.509, synthes lot number: 4605096, supplier lot number: a7ma21, release to warehouse date: (b)(6) 2003, manufacturing site: synthes monument , supplier: (b)(4) , no ncrs were generated during production.Device history batch null, device history review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.H3, h6: investigation summary service & repair evaluation.The customer reported the device fell apart from attachment.The repair technician reported that spring was worn, and ratchet came in parts.Loose component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: ratchet, spring(set) and all applicable components.The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2019 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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.

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.H6 - device codes: code 1371 was inadvertently applied to this report.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: 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: 8297785
• MDR Text Key: 134894324
• Report Number: 2939274-2019-56236
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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
• Device Lot Number: 4605096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1