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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER WITH PILOT DRILL 26 MM DIAMETER; INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. PATELLA REAMER WITH PILOT DRILL 26 MM DIAMETER; INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
It was reported that during a knee procedure, the drill bit fractured during removal of the reamer blade.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- drill.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified signs of repeated use (nicked / gouged / worn) and that it is fractured.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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
No further event information available at the time of this report.
 
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Brand Name
PATELLA REAMER WITH PILOT DRILL 26 MM DIAMETER
Type of Device
INSTRUMENT, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key16018065
MDR Text Key306355164
Report Number0001822565-2022-03559
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00597907726
Device Lot Number60131409
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/06/2022
Initial Date FDA Received12/20/2022
Supplement Dates Manufacturer Received12/27/2022
Supplement Dates FDA Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient SexMale
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