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

Model Number 311.43

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device has been 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 during a routine incoming inspection of a loaner set on an unknown date, the handle with quick coupling small was observed broken.There were no patient and surgical involvement.This report is for one (1) handle with quick coupling, small.This is report 1 of 1 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, h6: part#: 311.43, synthes lot#: 4702733, supplier lot#: na, release to warehouse date: 08 jan 2004, manufactured by synthes brandywine, no ncr's were generated during production.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: handle with quick coupling, small was received at us customer quality (cq).Upon visual inspection at cq, it is observed that the end cap of the handle was broken.The broken handle piece was not returned.No other issues were identified with the returned components of the device.Device failure / defect identified? yes: the device failure/defect of a broken handle was identified during the investigation.Dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage.Document/specification review: the following drawings were reviewed during the investigation: tap handle for small taps and csk.Complaint confirmed? yes.Conclusion: the overall complaint was confirmed for the received handle with quick coupling, small as the endcap was broken from the handle.Although no definitive root-cause can be determined the broken condition could have been caused due to application of unintended forces.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 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: 10636306
• MDR Text Key: 210033430
• Report Number: 2939274-2020-04533
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.43
• Device Catalogue Number: 311.43
• Device Lot Number: 4702733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1