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

Catalog Number 311.43

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 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 (b)(6) 2019, the handle with quick coupling was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves ten (10) devices.This is 4 of 10 for report (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, h6: part # 311.43.Synthes lot number: 7399736.Manufacturing site: synthes jennersville.Release to warehouse date: 21-jun-2013.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: visual inspections revealed that the device's handle was found to be cracked.The crack is lengthwise.There is nothing broken into two or multiple pieces.However, the complaint can be confirmed since the device was cracked.Device failure/ defect identified? yes dimensional inspection: dimensional inspection was not performed due to post manufacturing damages(crack condition).Document and specification review.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery).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: HANDLE WITH QUICK COUPLING, SMALL
• 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: 9322773
• MDR Text Key: 194616342
• Report Number: 2939274-2019-62175
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Device Lot Number: 7399736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1