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

Model Number RETROVERSION HNDL

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that during a surgical procedure, when removing a trial stem using the stem extractor, the surgeon accidentally struck the retroversion rod, causing the screw thread to snap off within the stem extractor tool.No fragments, pieces or parts fell into patient wound.Patient was last known to be in stable condition following the event.The device is available for return.

Manufacturer Narrative

Based on historical complaint investigations, the returned device, and the reported event, the broken retroversion handle reported was likely the result of the surgeon accidently impacting the retroversion handle while removing a trial stem, leading to ultimate failure of the retroversion handle.

• Brand Name: RETROVERSION HNDL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15325152
• MDR Text Key: 298947624
• Report Number: 1038671-2022-00975
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RETROVERSION HNDL
• Device Catalogue Number: 301-03-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female