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

Model Number	MODULAR IMPACTOR HANDLE
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 78 y/o male patient received a total shoulder replacement.Surgeon noticed a bb and small spring on patient x-rays and sent the images to sales rep.Sales rep researched the instruments and noticed the catch button missing on the modular impactor handle.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The device is available for evaluation.Additional information received indicates that the tip broke during the case, and no one noticed it until after sales rep had already left with the cleaned trays.The patient is ok, the surgeon states that he and the patient decided to leave the pieces where they are unless the patient starts having issues.Surgeon called sales rep and said he would keep watching it as well, he doesn¿t expect it to hurt or irritate anything.Furthermore, the device was used later at a different facility and no one there noticed it was broken, but somehow they made it work.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.Engineering drawings for the ergo and gps shoulder impactor handles referenced dimensions for the internal depth of the bore as well as a spherical radius to create the smaller diameter end opening for retention of the detent ball.Use of internal bore dimensions required an inspection method that may have contributed to damage and did not provide a method for dimensional inspection after assembly that may have resulted in nonconforming product being released to the field.A risk assessment has been initiated to escalate this issue.

• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16895059
• Report Number: 1038671-2023-00948
• Device Sequence Number: 12284950
• Product Code: HWA
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: MODULAR IMPACTOR HANDLE
• Device Catalogue Number: 321-09-05
• Device Lot Number: 275151004
• Date Returned to Manufacturer: 04/12/2023
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 09/29/2026
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 11/09/2023; 09/29/2026
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2050-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male