MAUDE Adverse Event Report: EXACTECH, INC. MODULAR IMPACTOR HANDLE

Model Number	321-09-05
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During surgical use, when the baseplate impactor tip was removed, a bearing and second small metal piece fell out of the end.Assuming the construct of the handle, is a bearing on each end and a metal piece between them, the second bearing was not accounted for.The, per dr parsons, concluded that it was highly unlikely that the second bearing made it into the surgical site.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: d4: lot number: 275151006.H3: the pin of the ergo impactor handle, that retains the ball and spring mechanism, became dislodged due to a failed weld holding in the retaining pin.The investigation showed the weld failed due to an insufficient weld call out on the engineering prints which lead to confusion between exactech and the manufacturing.Additionally, the manufacturer's process contributed to the weld failure.The manufacturer removed the filler material of the weld during post-processing/finishing of the device via a manual process.No detailed dfm conversations were had with the supplier to understand that the miscommunication of the weld call out was present.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d2a, d2b, d8, h6: medical device problem code, component codes, investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that during surgical use, and when the baseplate impactor tip was being removed, a ball bearing and second small metal piece fell out of the end.The surgeon noted if there was a bearing on each end and a metal piece between them, the second bearing was not accounted for.The surgeon concluded that it was highly unlikely that the second bearing made it into the surgical site.Additionally, a one-week post-operative radiograph was provided, and the surgeon confirmed no failed device components remained in-situ.The patient was last known to be in stable condition.

• Brand Name: MODULAR IMPACTOR HANDLE
• Common Device Name: IMPACTOR
• 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: 15537216
• Report Number: 1038671-2022-01235
• Device Sequence Number: 12531091
• Product Code: HWA
• UDI-Device Identifier: 10885862557674
• UDI-Public: 10885862557674
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 321-09-05
• Device Catalogue Number: 321-09-05
• Device Lot Number: 275151006
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 08/31/2023; 03/03/2026
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 09/20/2023; 03/10/2026
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male