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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN DRILL EXTREMITIES N/A

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ZIMMER GMBH UNKNOWN DRILL EXTREMITIES N/A Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative

He manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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). Item and lot numbers unknown.

 
Event Description

Journal article reported that during the implantation procedure drill bit broken intramedullary in one patient. The broken part was left in patient.

 
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Brand NameUNKNOWN DRILL EXTREMITIES
Type of DeviceN/A
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
5745273773
MDR Report Key9933251
MDR Text Key194006307
Report Number0009613350-2020-00177
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/07/2020 Patient Sequence Number: 1
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