MAUDE Adverse Event Report: EXACTECH, INC. GLENOID IMPACTOR TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	315-07-06
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after cementing in a caged glenoid the surgeon switched from the spider impactor to the normal impactor to pressurise the implant.After approx 5-10 minutes he impacted the handle once more with a mallet and the tip broke.He collated all the broken parts made sure he got everything out, washed out the wound and proceeded with the rest of the operation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
H3: the fractured glenoid impactor tip reported may have been the result of the mating impactor handle contacting the inner surface of the device upon impaction, transmitting the applied force to the tip of the device.Correction: h6 problem code.

• Brand Name: GLENOID IMPACTOR TIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannong ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19296351
• Report Number: 1038671-2024-01188
• Device Sequence Number: 6016187
• Product Code: LXH
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/04/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 315-07-06
• Device Lot Number: 115720020
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown