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

Model Number 352.040

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 on an unknown date that during an unknown surgery on (b)(6) 2019, the tip of two (2) flexible shafts were bent.Procedure and patient outcome are unknown.This is report 1 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.Investigation flow: damage.Visual inspection: the 5.0mm flexible shaft (part # 352.040/ synthes lot # 5652056/ supplier lot # 2292846) was received at us cq.The prongs of the distal coupling were severely bent.The part #/ lot # etch was also difficult to read as there was scratches/wear right on the etch.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes; distal coupling was bent, etch was illegible.Dimensional inspection: dimensional inspection could not be performed due to post-manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was confirmed for the received 5.0mm flexible shaft as the distal coupling¿s prongs were bent.Although no definitive root-cause can be determined it¿s possible the device experienced unintended forces during use/handling.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 history lot: part: 352.040, supplier lot: 2292846, synthes lot: 5652056, manufacturing site: bettlach, release to warehouse date: aug.31, 2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 9608279
• MDR Text Key: 191392468
• Report Number: 2939274-2020-00297
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• 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: 352.04
• Device Lot Number: 2292846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/07/2020
• Patient Sequence Number: 1