MAUDE Adverse Event Report: RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.033.001

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that on an unknown date, during insertion of a femoral recon nail, the threads of the driving cap were sheared off inside the insertion handle.No fragments were generated and the procedure was completed without additional delay.No patient consequences.This report is for one (1) radiolucent insertion handle frn.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Date of event: unknown date in 2021.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a device history record (dhr) review was conducted: part number: 03.033.001; lot number: 75p0031; manufacturing site: haegendorf; release to warehouse date: 18 january 2021; a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: RADIOLUCENT INSERTION HANDLE FRN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• MDR Report Key: 12555795
• MDR Text Key: 283479970
• Report Number: 2939274-2021-05825
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271051
• UDI-Public: (01)10886982271051
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.033.001
• Device Catalogue Number: 03.033.001
• Device Lot Number: 75P0031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRIVING CAP/THREADED.; UNK - NAILS: FEMORAL.