MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL; TAP, BONE

Model Number	310.95
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Mini quick coupling, stainless steel during set up.Issue was identified and resolved before patient involvement.There was no surgical delay.The procedure was successfully completed using a backup device.This report is for a handle.This is report 1 of 2 for (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2019, the screwdriver tip/head would not engage/lock in handle with mini quick coupling, stainless steel during set up.There was no surgical delay.The procedure was successfully completed using a backup device.
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.Part: 310.950; lot: 9530195; manufacturing site: bettlach; release to warehouse date: june 22, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Service and repair evaluation: the customer reported the device would not engage/lock in handle with mini quick coupling, stainless steel during set up.The repair technician reported the device required repairs due to failing functional test.Coupler damaged is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality (cq).The evaluation was confirmed.Visual inspection: the handle with mini quick coupling, stainless steel was received at us cq with minimal signs of wear on the device.Functional test: a functional test was completed by the service and repair department and it was found that the coupler is damaged and would not engage/lock.The complaint was able to be replicated.Therefore, the complaint is confirmed.Dimensional inspection: dimensional analysis was completed, the inner diameter where the screwdriver is inserted measured within specification, based on drawing.Document/specification review: the following drawings were reviewed: handpiece and kupplungsstueck (kpl) conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.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: HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8659302
• Report Number: 2939274-2019-58409
• Device Sequence Number: 19401747
• Product Code: HWX
• UDI-Device Identifier: 10886982187147
• UDI-Public: (01)10886982187147
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 310.95
• Device Catalogue Number: 310.95
• Device Lot Number: 9530195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1