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

Model Number 311.01

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history lot: part number: 311.01.Synthes lot number: 7822726.Supplier lot number: n/a.Release to warehouse date: 21oct2014.Expiration date: n/a.Manufactured by synthes jennersville.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 (b)(6) 2020, during set assembly at the sterile processing department (spd), two (2) handles with mini quick coupling would not easily accept drivers.There were no patient or surgical involvement.Concomitant device reported: unknown drivers (part#unknown, lot#unknown, quantity unknown) this report is for one (1) handle with mini quick coupling.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.H3, h4, h6- the handle with mini quick coupling was returned and received at us cq.Upon visual inspection, it was observed that there were scratches and nicks on the distal shaft of the device and the coupling feature of the device will not work.No other issues were observed with the returned components of the device.The functional test was not performed on the returned device as the quick coupling was received by itself.The customer reported the device would not easily accept drivers.The repair technician reported the device did not operate smooth and without binding.Supplier unable to repair 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.The evaluation was confirmed.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 did not seat properly.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed device history lot part number: 311.01, synthes lot number: 7822726 , supplier lot number: n/a, release to warehouse date: 21oct2014 , expiration date: n/a, manufactured by synthes jennersville.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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
• Type of Device: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9739266
• MDR Text Key: 191300882
• Report Number: 2939274-2020-00972
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187192
• UDI-Public: (01)10886982187192
• 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: 01/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 311.01
• Device Catalogue Number: 311.01
• Device Lot Number: 7822726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDLE WITH MINI QUICK COUPLING; UNK - POWERED DRIVERS/HANDPIECES