MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS; PLIERS,SURGICAL

Model Number 388.50

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.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 during a routine inspection on (b)(6) 2018, the issue tabs on a rod introduction pliers for side-opening implants were found to be splayed.The sleeve is also stuck on the tube and will not move.It was also noted that the ratchet on another rod introduction pliers for side-opening implants falls off and will not stay on the instrument.There was no patient involvement.This report is for one (1) rod introduction pliers for side-opening implants.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

The device has been 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.

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.H3, h4, h6: dhr review was completed.Part number: 388.50 , synthes lot number: t134820 , release to warehouse date: 26-oct-2016 , manufacture site: tuttlingen , part expiration date: n/a , list of nonconformance¿s: (b)(4).A non-conformance was started for the subcomponent 208.0319 (work order (b)(4)) because the diameter ø8,90 +0,05 was too small (was 8,89).The lot were checked for 100% and the parts were scrapped.The ncs have no impact on the complaint issue and were found confoming at the final inspection.Further review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.Cq engineering addition: review of non-conformance showed that this impacted the shaft on the distal end of the device.It was determined that this would have no impact on the ratchet and spring on the proximal end of the device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint h3, h6: customer quality conducted an investigation of the returned device.Service and repair evaluation: the repair technician reported the ratchet and spring were worn, and the collet was damaged.Damaged component is the reason for repair.The item is not repairable per the inspection sheet and will be forwarded to customer quality.The evaluation was confirmed.Cq device evaluation: investigation flow: device interaction/functional and damage: visual (appearance not as expected) visual inspection: the device was inspected at monument and images were provided; incomplete engagement of the retched with the spring was observed.The spring shows bending away from the ratchet and scraping of the surface which mates with the ratchet.The proximal edge of the collet also shows indents.The balance of the device shows surface wear consistent with use and which would not impact the functionality.Functional test: functional testing was also completed at monument where it was observed that the ratchet is loose in the handle.During testing, the ratchet easily falls out of place when it is in the track.Thus, it is determined that the received condition does agree with the complaint description and can be replicated with the returned device.Dimensional inspection: document/specification review: the following drawings, reflecting the current and manufactured revision, were reviewed.Release to warehouse date: 26-oct-2016 --rod introduction forceps for side opening implants: --handle assemble (component): the design history was found to not impact the complaint condition since the only design revision since the date of manufacture concerns the udi etching.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Dimensional inspection: dimensional inspection of curved tapered end of the spring which mates with the ratchet could not be conducted due to the post manufacturing deformation.Inspection of the collet at the location of the indents was deemed not relevant as the dents are consistent with post manufacturing impact, not a dimensional issue.Conclusion: the complaint condition is confirmed as the ratchet is loose in the handle due to the bending and wear to the spring component resulting in additional clearance.No definitive root cause was able to be determined as circumstances surrounding the event and over the 2 year lifespan of the device are unknown.However, the condition is consistent with an applied forced from use and/or handling to the spring resulting in the spring bending away from the mating ratchet.No design or manufacturing defect or deficiency was observed during the investigation.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 SIDE-OPENING IMPLANTS
• 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: 7950145
• MDR Text Key: 123403684
• Report Number: 2939274-2018-54281
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10705034773292
• UDI-Public: (01)10705034773292
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 388.50
• Device Catalogue Number: 388.50
• Device Lot Number: T134820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1