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

Model Number 314.291

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2022

Event Type  malfunction  

Event Description

It was reported intraoperatively on (b)(6), 2022, during a retrograde femoral nail, they went to use the collinear clamp to aid us in our reduction and the tensioning gun would not hold tension.There was 20 mins of surgery delayed due to the reported event.They had to use a different clamp and make bigger incision to aid in their reduction.Procedure was successfully completed.No fragments were generated.Patient outcome was unknown.Other medical intervention required was unknown.This is report 1 of 1 for (b)(4).This report is for a sliding mechanism.

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is j&j company representative.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.

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, h4, h6: part 314.291, lot 10-3418: release to warehouse date: november 22, 2010.Supplier: (b)(4).No non-conformance reports (ncr's) 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.H3, h6: a service and repair evaluation was completed: the customer reported the during a retrograde femoral nail, they went to use the collinear clamp to aid us in our reduction and the tensioning gun would not hold tension.The repair technician reported missing synthetic screen and release plate spring.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is missing parts.The evaluation was confirmed.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
• Manufacturer (Section G): BACHLER FEINTECH AG; postfach; hölstein 4434 ; SZ 4434
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14396303
• MDR Text Key: 291972416
• Report Number: 2939274-2022-01750
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982188779
• UDI-Public: (01)10886982188779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 10-3418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1