MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Model Number 352.040

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is company representative; no facility information available.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 (b)(6) 2019, the flexible shaft was bent in the center.The deformation would cause it to wobble in the canal while reaming if used in its current condition.This instrument was not broken during a case.The issue was found in the sterile processing.There was no patient involvement.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part: 352.040.Lot: 8113661.Manufacturing site: bettlach.Release to warehouse date: 25.Oct.2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 5.0mm flexible shaft (p/n 352.04s/n 8113661) was received at customer quality, and upon visual inspection, it was observed that the shaft of the device was bent.No other issues were observed in the returned portions of the device.The complaint condition is confirmed.Device failure/ defect identified? yes, the device was bent.Dimensional inspection: conclusion: the measuring result does show conformity.Document/ specification review: a review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.Complaint confirmed? yes.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.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: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9512465
• MDR Text Key: 196115517
• Report Number: 2939274-2019-62743
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.040
• Device Catalogue Number: 352.040
• Device Lot Number: 8113661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1