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

Model Number 314.291

Device Problem Device-Device Incompatibility (2919)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020, the surgeon was attempting to use a synthes collinear clamp on a proximal femur fracture and the clamp would not tighten properly.The clamp tightened while the surgeon was squeezing the trigger/handle but it would loosen once the trigger was released rather than remain tight.The collinear clamp was removed and a loman was applied.There was a surgical delay of fifteen minutes because, it took the surgeon approximately fifteen minutes to remove the collinear clamp, extend his incision, and apply a loman clamp.The fracture was able to be reduced.The procedure was successfully complete.This is report 2 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.D10 h3, h6: part number: 314.291, lot number: 09-3956, manufacturing location: selzach, supplier: (b)(4), release to warehouse date: 21 aug 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The repair technician reported the device is sticky when operating, device is missing screens, lube, oil, clean.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: synthetic screen and all other applicable components.The item was repaired per the inspection sheet, passed synthes final inspection on 16-oct-2020 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.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.H6: code 3191 used to capture modified surgical procedure.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: 10727144
• MDR Text Key: 212746688
• Report Number: 2939274-2020-04799
• 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: 09/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.291
• Device Catalogue Number: 314.291
• Device Lot Number: 09-3956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 09/26/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Treatment: BONE HOOK-SHAPE ARM 206MM; BONE HOOK-SHAPE ARM 206MM
• Patient Outcome(s): Required Intervention