MAUDE Adverse Event Report: EXACTECH, INC. IMPCTR HNDL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	321-07-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during an anatomic shoulder replacement at the oaks hospital, the glenoid was prepared as per operative surgical technique.When cementing the glenoid, the implant was placed into correct position in line with the surgical plan, the surgeon was using the impactor handle with tip attached to pressurize the implant while waiting for cement to set.Once the cement had set the surgeon handed the impactor handle back to the agency scrub nurse and the end of the impactor handle had sheared off.No parts of the instrument landed within the surgical site, all parts were put to one side and both surgeon and scrub nurse changed there surgical gloves to continue the procedure.Patient was last known to be in stable condition following the event.No patient/medical information provided.Images attached.Unable to obtain x-rays.Product is available for return.
Additional Manufacturer Narrative
(h3) based on historical complaint investigations, the image of the device, and the reported event, the fracture reported was likely the result of surgical use and subsequent sterilization cycles, which led to degradation and ultimate fracture of the weld at the strike plate-handle interface during impaction.The following sections have corrected information: (d1) brand name: glenoid impactor tip.(d4) catalog number: 315-07-06, unique identifier (udi) #: (b)(4).(h6) component code: 3195, weld.
Additional Manufacturer Narrative
Section h11: *the following sections have corrected information: (d1) brand name: impctr hndl.Lot number: 400801008.Catalog number: 321-07-05.Unique identifier (udi) #: (b)(4).(h3) based on historical complaint investigations, the returned device, and the reported event, the fracture reported in (b)(4) was likely the result of fatigue from numerous impaction forces, which led to crack initiation, propagation, and ultimate fracture at the strike plate-handle interface.(h6) component code: 3195, weld.Type of investigation: 10, testing of actual/suspected device; 4109, historical data analysis.

• Brand Name: IMPCTR HNDL
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17139600
• Report Number: 1038671-2023-01365
• Device Sequence Number: 12255375
• Product Code: LXH
• UDI-Device Identifier: 10885862087140
• UDI-Public: 10885862087140
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/01/2023

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 Catalogue Number: 321-07-05
• Device Lot Number: 400801008
• 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: 05/21/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/10/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/26/2023; 11/01/2023
• 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
• Patient Sex: Unknown