MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP; FORCEPS

Model Number 03.118.111

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part: 03.118.111.Lot: t158543.Manufacturing site: (b)(4).Release to warehouse date: january 04, 2018.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.The raw material certificate was reviewed, and the used material was according to the specification of the device.Service and repair evaluation: during a routine incoming inspection of a loaner set at fsl ups (b)(4) site on an unknown date, the silicone handle/quick coupling with rotating cap was observed broken.The repair technician reported the sleeve is bent.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: quick coupling sleeve.The item was repaired per the inspection sheet, passed synthes final inspection, and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore 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.

Event Description

It was reported that during a routine incoming inspection of a loaner set at fsl ups (b)(4) site on an unknown date, the silicone handle/quick coupling with rotating cap was observed to be broken.There were no patient and surgical involvement.This report is for a silicone handle/quick coupling w/ rotating cap.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10437158
• MDR Text Key: 204255998
• Report Number: 2939274-2020-03718
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982073686
• UDI-Public: (01)10886982073686
• 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: 07/28/2020

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: 03.118.111
• Device Catalogue Number: 03.118.111
• Device Lot Number: T158543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1