MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT 620MM; REAMER

Model Number 352.044

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Event year is reported as 2021; however the exact date of device breakage is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a j&j sales representative.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 unknown date, the prong of the flexible reamer shaft was bent and broken.It was found after it came out of the wash.The prong piece was missing.No patient was involved.This report is for one (1) 5.0mm flexible shaft 620mm.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: h3, h4, h6: part 352.044, lot 2593839: manufacturing site: bettlach.Release to warehouse date: may 14, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, one of the prongs on the tip of the shaft was broken.Additionally, scratches were observed on the shaft which were consistent with the field usage.No other issues were identified with the device.No dimensional inspection was performed due to post-manufacturing damage.Based on the date of manufacture the following drawing, reflecting the current and manufactured revision was reviewed; no design discrepancies were identified during the document review.This complaint is confirmed as one of the prongs on the tip of the shaft was broken.No definitive root cause could be determined based on the provided information.However, the deformation observed could have been a result of the device experiencing unintended forces.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 620MM
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11400147
• MDR Text Key: 234471556
• Report Number: 2939274-2021-01127
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194138
• UDI-Public: (01)10886982194138
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.044
• Device Catalogue Number: 352.044
• Device Lot Number: 2593839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1