MAUDE Adverse Event Report: SYNTHES GMBH TI LCP DISTAL FEMUR PLATE 11 HOLES/276MM/LEFT-STERILE; PLATE, FIXATION, BONE

Catalog Number 422.257S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this (b)(4) is related to (b)(4) which reports about the 1st revision surgery with the external fixation instruments.It was reported that, the surgeon could not remove the 3 distal screws and closed the incision with the plate in the 2nd revision surgery on (b)(6) 2021 and screws remained in the patient.On (b)(6) 2020, the patient underwent the surgery for diaphyseal fracture with the distal femoral plate in question.On an unknown date, it was found that the plate was broken, and 1st revision surgery was performed with external fixation instruments.This report is for one (1) ti lcp distal femur plate 11 holes/276mm/left-sterile.This is report 1 of 4 for complaint (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.D4, h4, h6: a device history record (dhr) review was conducted: product code: 422.257s, lot number: 60p9139, manufacturing site: grenchen, release to warehouse date: 2 july 2020, and expiry date: 01 july 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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: TI LCP DISTAL FEMUR PLATE 11 HOLES/276MM/LEFT-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12375647
• MDR Text Key: 268461122
• Report Number: 8030965-2021-07240
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819289659
• UDI-Public: (01)07611819289659
• Combination Product (y/n): N
• PMA/PMN Number: K062564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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 Catalogue Number: 422.257S
• Device Lot Number: 60P9139
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/27/2021
• Patient Sequence Number: 1
• Treatment: UNK - EXTRACTION INSTRUMENTS: TRAUMA; UNK - SCREWS: DISTAL FEMUR; UNK - SCREWS: DISTAL FEMUR; UNK - EXTRACTION INSTRUMENTS: TRAUMA; UNK - SCREWS: DISTAL FEMUR; UNK - SCREWS: DISTAL FEMUR