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

Model Number	301-03-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke.Surgeon impacted on retroversion handle while removing broach.No parts or pieces fell into the patients wound.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) based on historical complaint investigations, the returned device, and the reported event, the broken retroversion handle reported in case-2022-00005606 was likely the result of the surgeon accidently impacting the retroversion handle while removing the broach, leading to ultimate failure of the retroversion handle.Section h11: *the following sections have corrected information: (h6) component code: 4721, rod/shaft.

• Brand Name: RETROVERSION 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: 14943981
• Report Number: 1038671-2022-00761
• Device Sequence Number: 12315759
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/08/2022

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: 301-03-10
• Device Catalogue Number: 301-03-10
• Device Lot Number: 51369001
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 12/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown