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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT GAUGE,DEPTH

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SYNTHES GMBH INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT GAUGE,DEPTH Back to Search Results
Catalog Number 03.113.025
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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 during an lcp medial distal tibia internal fixation with jig procedure, the aiming arm and insertion handle did not align with lcp holes. The surgeon was unable to use these instruments for percutaneous insertion. There was no surgical delay. The procedure was successfully completed. There was no patient consequence. Concomitant device reported: unknown tibial plate (part # unknown, lot # unknown, quantity unknown). This report is for one (1) insertn handle f/3. 5mm low bnd medial distal tib plate/right. This is report 2 of 2 for (b)(4).
 
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Brand NameINSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT
Type of DeviceGAUGE,DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11102229
MDR Text Key224599626
Report Number8030965-2020-10084
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.113.025
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 Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/31/2020 Patient Sequence Number: 1
Treatment
PERCUTANEOUS AIMING ARM R F/LCP MED DIST; UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE
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