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	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The instrument could have been broken during the surgery.However, the breakage has been noticed at the recovery of the instrumentation-set by our 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
Pending investigation.
Additional Manufacturer Narrative
H3: the broken instrument reported may have been the result of a stress riser, secondary to years of surgical use or unauthorized disassembly of subcomponents for cleaning, which led to crack initiation, propagation, and ultimate failure of the black radel sphere subcomponent.

• 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: 15660040
• Report Number: 1038671-2022-01347
• Device Sequence Number: 20442185
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2026

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: 47919021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 02/13/2023; 07/24/2026
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/28/2023; 07/27/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown