MAUDE Adverse Event Report: EXACTECH, INC. PRM STM INSRTR EXTRCT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	301-07-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, the instrument could have been broken during the surgery.However, the breakage was noticed at the recovery of the instrumentation set by the logistics dept., after the cleaning realized by the sterilization team of the hospital.No information has been received from the hospital regarding this issue and xnov ip didn't receive any request for complementary information regarding this issue as well.
Additional Manufacturer Narrative
H3: the broken instrument reported may have been the result of unauthorized disassembly of subcomponents for cleaning and not properly re-assembling the subcomponents after cleaning, which led to the missing subcomponent.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: PRM STM INSRTR EXTRCT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15867343
• Report Number: 1038671-2022-01507
• Device Sequence Number: 5162061
• Product Code: LXH
• UDI-Device Identifier: 10885862079701
• UDI-Public: 10885862079701
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: 301-07-10
• Device Catalogue Number: 301-07-10
• Device Lot Number: 48685001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 02/13/2023; 02/11/2026
• Initial Report FDA Received Date: 11/27/2022
• Supplement Report FDA Received Date: 02/28/2023; 02/12/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown