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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL SIZE EF 10 MM HEIGHT; TEMPLATE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL SIZE EF 10 MM HEIGHT; TEMPLATE Back to Search Results
Catalog Number 00596104010
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returning to zimmer biomet for evaluation as the product has been discarded.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
 
Event Description
It was reported that during the trialing process of an initial total knee arthroplasty, the articular surface provisional instrument fractured into two pieces when the surgeon bumped it with a hammer.No patient impact or adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
 
Event Description
No further event information at time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to failure of the operator to follow instructions.It was reported that the device was struck with a hammer and the instructions for use indicate that breakage can occur if the instrument is subject to high loads or impact.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 Name
ARTICULAR SURFACE PROVISIONAL SIZE EF 10 MM HEIGHT
Type of Device
TEMPLATE
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 Key17210189
MDR Text Key317956878
Report Number0001822565-2023-01708
Device Sequence Number1
Product Code HWT
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/12/2023
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 Catalogue Number00596104010
Device Lot Number61716991
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/07/2023
Initial Date FDA Received06/27/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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