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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. 3 PEG PATELLA TRIAL 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

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EXACTECH, INC. 3 PEG PATELLA TRIAL 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Model Number 201-02-35
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2022
Event Type  malfunction  
Manufacturer Narrative
Pending device return and investigation.
 
Event Description
As reported, during trialing with the 35mm patella trial, while removing the patella trial one of the patella pegs broke off inside the patient.The surgeon was able to remove the nub using a drill.This led to a surgical delay of about 5 minutes.The patient was last known to be in stable condition following the event.
 
Manufacturer Narrative
H3: the broken instrument reported was likely the result of numerous surgical uses and subsequent sterilization cycles over a 17-year timespan, which resulted in a fractured peg during removal.However, this cannot be confirmed as the device was not returned for evaluation.
 
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Brand Name
3 PEG PATELLA TRIAL 35MM
Type of Device
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key15883540
MDR Text Key304505417
Report Number1038671-2022-01529
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10885862041760
UDI-Public10885862041760
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/03/2023
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 Number201-02-35
Device Catalogue Number201-02-35
Device Lot Number8225-3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/09/2022
Initial Date Manufacturer Received 11/09/2022
Initial Date FDA Received11/29/2022
Supplement Dates Manufacturer Received02/17/2023
Supplement Dates FDA Received03/03/2023
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 Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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