MAUDE Adverse Event Report: EXACTECH, INC. 3 PEG PATELLA TRIAL 38MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	201-02-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during a left tkr, this event happened when the surgeon started trialing the implants.While removing the 38mm patella a peg snapped off inside the patient.The surgeon tried to remove the peg with various instruments without any success and eventually had to redrill the hole to remove the peg.No parts or pieces were left in the patient.There was a less than 5 min delay that did not result in an adverse event.Patient was last known to be in stable condition following the event.Device will be retuning.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 14594005.(h3) the broken instrument reported may have been due to material degradation as a result of numerous surgical uses and subsequent sterilization cycles, which led to patella peg fracture during removal.Section h11: the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: 3 PEG PATELLA TRIAL 38MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14999054
• Report Number: 1038671-2022-00785
• Device Sequence Number: 13923463
• Product Code: LXH
• UDI-Device Identifier: 10885862041777
• UDI-Public: 10885862041777
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 201-02-38
• Device Catalogue Number: 201-02-38
• Device Lot Number: 14594005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male