MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING; REAMER

Model Number	351.15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during a procedure involving im rodding of tibia, the flexible shaft handle broke off during insertion/rotation.There was a surgical delay of five (5) minutes.The procedure was successfully completed using a replacement handle.There was no patient consequence.This report is for one (1) flexible shaft handle with quick coupling.This is report 1 of 1 for (b)(4).
Additional 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 summary the following investigation is performed both on the physical device returned and the pictures provided.Investigation flow: damage.Visual inspection: the t-handle w/quick-coup (p/n: 351.150, lot #" 2221287) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was received disassembled and all the components received were fell apart as the device was missing a screw component to hold the device.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: there was conclusive evidence that the returned device was missing a component, so the dimensional inspection will not be performed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed t-handle w/quick coupling.D0006648, rev.00 (manuf.).Complaint confirmed? yes, the device received was missing a component.Hence confirming the allegation.Investigation conclusion : the complaint condition is confirmed for the t-handle w/quick-coup (p/n: 351.150, lot #" 2221287).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance or incorrectly assembled during the sterilization process.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 number: 351.150, lot number: 2221287, manufacturing site: bettlach, release to warehouse date: sept 27, 2006.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: FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10488505
• Report Number: 2939274-2020-03958
• Device Sequence Number: 2676148
• Product Code: HTO
• UDI-Device Identifier: 10886982193728
• UDI-Public: (01)10886982193728
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 351.15
• Device Catalogue Number: 351.150
• Device Lot Number: 2221287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - FLEXIBLE SHAFTS; UNK - FLEXIBLE SHAFTS