MAUDE Adverse Event Report: EXACTECH, INC. HEAD PUSHER, MOD, LOWPRO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	01-001-03-0001
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the rep was putting trays back together in spd and noticed that the edge of the head impactor was chipped.The rep is not sure when the impactor edge was damaged.His guess is during post-op cleaning process.It was not noticed in cases and did not affect any procedures.Because two cases were done that day, the rep is unsure which case the impactor was used on.The patients were last known to be in stable condition following the events.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
The broken device reported was likely the result of stress risers introduced during impaction which led to crack initiation, propagation, and ultimate fracture of the devices.
Additional Manufacturer Narrative
H1: corrected medical device problem code, type of investigation, investigation findings, and investigation conclusions.

• Brand Name: HEAD PUSHER, MOD, LOWPRO
• 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: 17858150
• Report Number: 1038671-2023-02430
• Device Sequence Number: 14934918
• Product Code: LXH
• UDI-Device Identifier: 10885862256607
• UDI-Public: 10885862256607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/11/2024

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 Catalogue Number: 01-001-03-0001
• Device Lot Number: 97005005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 11/11/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/15/2023; 11/11/2024
• 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