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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY TARGETING GUIDE STANDARD ROD, FIXATION

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ZIMMER BIOMET, INC. CEPHALOMEDULLARY TARGETING GUIDE STANDARD ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Expected, not yet received.
 
Event Description
It was reported during a procedure, the surgeon implanted the nail and went to use the targeting guide to implant the distal screws. However, the screws missed the posterior holes and the drill guide did not line up as intended. Due to the event there was a ten minute delay in procedure. Further, the surgeon removed the targeting guide and free-handed inserting the screws.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Updated:corrected: lot number product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
Lot number received.
 
Event Description
No additional information provided.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned product noted general wear on the instrument indicative of use. The distal screw holes were damaged which would contribute to the misalignment, however, it is unknown when and how the guide was damaged. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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Brand NameCEPHALOMEDULLARY TARGETING GUIDE STANDARD
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7992991
MDR Text Key124665194
Report Number0001822565-2018-05830
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00249000300
Device Lot Number63180825
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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