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 Break (1069)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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: it was reported that on (b)(6) 2020, the patient underwent the surgery with locking compression (lcp) distal femur plate.On (b)(6) 2021, it was confirmed that the plate had been broken.The date of the breakage is unknown.No further information is available.This report is for one (1) ti lcp distal femur plate 11 holes/276mm/left-sterile this is report 1 of 1 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.Product complaint # (b)(4).Investigation summary : product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : part: 422.257s , lot: 60p9139, manufacturing site: grenchen, release to warehouse date: 20.Jul.2020, expire date: 01.Jul.2030.A manufacturing record evaluation was performed for the finished device 422.257s lot: 60p9139 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: 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: 11609165
• MDR Text Key: 243617869
• Report Number: 8030965-2021-02566
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 04/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention