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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH AWL 12MM

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SYNTHES GMBH AWL 12MM Back to Search Results
Catalog Number 03.820.100
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the surgeon was using the awl and noted that it was blunt. The surgeon was able to continue to use the awl, however. Procedure was completed successfully with no delay. There was no patient consequence. This report is for a awl 12mm. This is report 1 of 1 for (b)(4).

 
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Brand NameAWL 12MM
Type of DeviceAWL
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11790624
MDR Text Key249519968
Report Number8030965-2021-03691
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/13/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number03.820.100
Device LOT NumberT166392
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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