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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH AWL N/A

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ZIMMER GMBH AWL N/A Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 09/19/2019
Event Type  Injury  
Manufacturer Narrative

The manufacturer did not receive x-rays but received other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. Attempts to obtain additional information have been made; however, no more is available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during surgery the instrument got stuck in the femur canal. When the surgeon tried to take it out, the handle came off and the reamer got stuck in the patient. It took one hour to take out the stuck reamer.

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Brand NameAWL
Type of DeviceN/A
Manufacturer (Section D)
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
MDR Report Key9144173
MDR Text Key165552968
Report Number0009613350-2019-00583
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device MODEL NumberN/A
Device Catalogue Number70.08.89
Device LOT Number05.168339
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/27/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Date Received: 10/02/2019 Patient Sequence Number: 1