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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER PLATE,FIXATION,BONE

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SYNTHES GMBH 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER PLATE,FIXATION,BONE Back to Search Results
Model Number 02.118.207S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
Additional procode: hwc. 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) 2021 during an unknown procedure, the va-lcp distal tibial plate could not fit the va screw in one of the holes. The surgeon attempted to use another screw but that did not fit into the plate hole either. There was no patient consequence. There is no further information available. This report is for one (1) 2. 7/3. 5mm va-lcp anterolateral distal tibia pl/8 h/lt-ster. This is report 1 of 1 for (b)(4).
 
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Brand Name2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11992604
MDR Text Key255987666
Report Number8030965-2021-04904
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K121601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.118.207S
Device Catalogue Number02.118.207S
Device Lot Number25P6747
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 Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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