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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CLS - AWL, EXTENDED UNKNOWN

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ZIMMER GMBH CLS - AWL, EXTENDED UNKNOWN Back to Search Results
Catalog Number 70.08.89
Device Problems Material Separation (1562); Naturally Worn (2988); Torn Material (3024)
Patient Problem No Information (3190)
Event Date 01/08/2016
Event Type  Injury  
Manufacturer Narrative

The manufacturer did not receive devices or other source documents for review. Where lot numbers were received for the devices, the device history records were reviewed. The device manufacturing quality records indicate that the released components met all requirements to perform as intended. A cause for this specific event cannot be ascertained from the information provided. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. Zimmer's reference number of this file is (b)(4).

 
Event Description

It was reported, that "welding is coming apart and is sharp" on (b)(6) 2016 on a cls - awl, extended. This was discovered by the sterilization team after surgery. The product is normal worn and torn.

 
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Brand NameCLS - AWL, EXTENDED
Type of DeviceUNKNOWN
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582-0708
5745273773
MDR Report Key5398594
MDR Text Key37105198
Report Number9613350-2016-00133
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device Catalogue Number70.08.89
Device LOT Number06.229088
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/02/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/19/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 01/29/2016 Patient Sequence Number: 1
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