MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDING MECHANISM; FORCEPS

Model Number 314.291

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes 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 on an unknown date, when opening a set for a case, it was noticed that the sliding mechanism handle was broken.There was no procedure and patient involvement.This report involves one (1) sliding mechanism.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.H10 additional narrative: h3, h6: a product investigation was conducted.Service and repair evaluation: the customer reported that the sliding mechanism handle was broken.The repair technician reported the handle is cracked and broken.Handle cracked broken is the reason for repair.The cause of the issue is handle cracked/broken.The item is not repairable per the inspection sheet.The cause of the issue is failed high.The item will be forwarded to customer quality.The evaluation was confirmed.Visual inspection: sliding mechanism (part.No: 314.291, lot.No: 180301-102) was received at us cq.Upon visual inspection at cq, it is observed that the black polyamide handle is broken at the distal attachment screw.The broken part was received at cq.The two screws which are holding the handle are still in place, remaining within the instrument.The lot number etched on the device was faded and hardly visible.Thus, the complaint is being confirmed.Dimensional inspection: dimensional analysis around other parts of the broken handle could not be measured due to the post manufacturing damage and geometry of the device.Documentation/ specification review: the relevant drawing(s) was reviewed; no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for sliding mechanism (part.No: 314.291, lot.No: 180301-102, qty: 1) as the handle of the device was broken.While a definitive root cause could not be determined for the broken handle, but there is high possibility that the device might have encountered unintended forces.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 314.291.Lot number: 180301-102.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 29.Nov.2018.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: SLIDING MECHANISM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10459325
• MDR Text Key: 204568399
• Report Number: 2939274-2020-03815
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982188779
• UDI-Public: (01)10886982188779
• 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: 08/03/2020

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: 314.291
• Device Catalogue Number: 314.291
• Device Lot Number: 180301-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1