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

Model Number 352.044

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a company sales representative.No other reporter information available.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 an unknown date, during a demonstration, the reamer/flexible shaft keeps binding up on the ball tip 2.5 mm guide wire and creating a groove in the wire.This would cause problems if it happened during a case.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.Part: 352.044; lot: l710619; manufacturing site: bettlach; release to warehouse date: january 12, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: 5.0mm flexible shaft 620mm was received at customer quality (cq).Upon visual inspection at cq, it was observed that the distal prongs of the flexible reamer shaft were deformed and farther apart than they are intended to be.The complaint is confirmed.The remaining portions of the device show minimal wear which would not contribute to the complaint condition.Functional testing: functional test cannot be performed as the device, flexible shaft, was received by itself.Dimensional inspection: dimensional inspection of the kuppling (component of the flexible reamer shaft) was performed at cq.The distance between the outer ends of the distal prongs was measured to be out of specifications.Thus, the complaint is confirmed.Document review: the following drawing(s) was reviewed; flex.Welle d7.0mm, bohrtiefe bis 620mm (flexible reamer shaft assembly) , kuppling.No design issues or discrepancies were found during this investigation.Investigation conclusion: this complaint is confirmed.Visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.A definitive root cause could not be determined.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: 8695706
• MDR Text Key: 147895918
• Report Number: 2939274-2019-58626
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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: L710619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1