MAUDE Adverse Event Report: EXACTECH, INC. MODULAR IMPACTOR ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	351-10-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, the impactor handle broke during use.No fragments, parts or pieces fell into the patient or the wound site.The reported event did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
This event was reported in error.As reported, the impactor handle broke during use.No fragments, parts or pieces fell into the patient or the wound site as this device is not used over/near the open wound.The reported event did not lead to a surgical delay/prolongation or injury to the patient and does not have a history of past injuries.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the broken instrument reported was likely the result of improper use of the device during surgical procedure, as supported by durability testing, review of instrumentation design, and operative technique.
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: MODULAR IMPACTOR ARM
• 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: 15996027
• Report Number: 1038671-2022-01606
• Device Sequence Number: 12260910
• Product Code: LXH
• UDI-Device Identifier: 10885862318015
• UDI-Public: 10885862318015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 08/14/2025

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: 351-10-13
• Device Catalogue Number: 351-10-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 02/17/2023; 08/08/2025
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/13/2023; 03/03/2023; 08/14/2025
• 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