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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN REAMER GUIDE INSTRUMENT

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ZIMMER BIOMET, INC. UNKNOWN REAMER GUIDE INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Positioning Failure ; Difficult to Insert
Event Date 11/20/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06916. Concomitant medical products: item #: 00597909541, lot #: 64093400. Foreign report source: (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Medical records were not provided. The damaged/bent tabs in the reamer blade show the damages might be caused during the mating process and causes the mating issue. But, sufficient information was not provided to support this claim as the reamer guide used in procedure was not returned. A definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that a new 41 mm patella reamer blade didn't fit with the reamer guide during a total knee arthroplasty. Subsequently, a 46 mm reamer blade was alternatively used to complete the procedure. No adverse events have been reported as a result of the malfunction. Attempts have been made and no further information has been provided.

 
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Brand NameUNKNOWN REAMER GUIDE
Type of DeviceINSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key9207448
Report Number0001822565-2019-04507
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN REAMER GUIDE
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 Received10/17/2019
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
Removal/Correction NumberN/A

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