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 Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on (b)(6) 2019, the two (2) rod introduction pliers for dual-opening implants would not load or hold the collars.There was no patient involvement.This report is for a rod introduction pliers.This is report 2 of 2 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.Device history lot: part # 388.509.Synthes lot # h387389.Supplier lot # h387389.Release to warehouse date: 14 sep 2018.Supplier: diener gmbh.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary background: it was reported that on (b)(6) 2019, the two (2) rod introduction pliers for dual-opening implants would not load or hold the collars.There was no patient involvement.This complaint involves two (2) devices.Service & repair evaluation: the customer reported that the rod introduction pliers for dual-opening implants would not load or hold the collars.The repair technician reported that no issues were found.Warranty replacement is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation flow: functional/ device interaction.Visual inspection: rod introduction pliers for dual-opening impl f/6.0mm rods was received at cq.Upon visual inspection, the device looks good without any damage and no surface wear.Functional test: functional test cannot be performed as the rod introduction pliers for dual-opening impl f/6.0mm rods was received by itself.Dimensional inspection: the distance between the prongs of the device when the ratchet bar is holding the prongs was intended to be ranging from 98mm to 114mm and was measured to be 110mm which is within specifications.Document/ specification review: the following drawings were measured during this investigation: rod introduction pliers uss 11, with collet: 388_509 rev.G and handle assembly rod introduction forceps: 388_50_1 rev.E.Dhr review: review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation conclusion: visual inspection of the device received, dhr review and document specification review were performed at cq.Functional testing of the device was performed and found that the device was working as intended.Thus, the complaint is not confirmed.A definitive root cause for the reported condition could not be determined based on the provided information.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, 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.

• 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: 8531229
• MDR Text Key: 142494188
• Report Number: 2939274-2019-57566
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• 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: H387389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1