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U.S. Department of Health and Human Services

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

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SYNTHES GMBH TI LCP DISTAL FEMUR PLATE 11 HOLES/276MM/LEFT-STERILE PLATE, FIXATION, BONE Back to Search Results
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).

 
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Brand NameTI LCP DISTAL FEMUR PLATE 11 HOLES/276MM/LEFT-STERILE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12375647
MDR Text Key268461122
Report Number8030965-2021-07240
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK062564
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number422.257S
Device LOT Number60P9139
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/02/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/26/2021 Patient Sequence Number: 1
Treatment
UNK - EXTRACTION INSTRUMENTS: TRAUMA; UNK - SCREWS: DISTAL FEMUR; UNK - SCREWS: DISTAL FEMUR
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