MAUDE Adverse Event Report: ACUMED, LLC T8 STICK FIT HEXALOBE DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 80-0759

Device Problem Material Twisted/Bent (2981)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.Two (2) drivers were returned for evaluation.The returned products were inspected under magnification.Under magnification, the batch numbers of the t8 stick fit hexalobe drivers (80-0759) were confirmed as 530524 and 540134.The first driver ( batch number 540134) showed slight signs of twisting at the lobes of the driver tip as they curved nearing the very end of the driver tip.The second driver showed a fractured surface at its end and was returned alongside a fragment of the driver tip.Both the remaining driver shaft and the fractured tip showed an angled, torsional fracture pattern.The remaining drier tip fragment measured approximately 0.118 inches.A torsional fracture pattern likely indicates an excessive twisting load about the driver's central axis.Noticeable twisting of the hexalobe feature additionally indicates an excessive twisting load about the driver's central axis.Hexalobe tip twisting or breakage may occur when excessive force is applied to the driver during use to overcome increased resistance.In a screw removal case there may be significant growth between the bone and the implant which contributes to the increased torque required to remove the implant.However, no definitive root cause could be determined.

Event Description

It was reported during a routine removal procedure, one driver tip broke and one driver tip twisted.The broken driver tip fragment was able to be retrieved.This issue prolonged the surgery by 30 minutes.No adverse patient consequences were reported.This report is related to report numbers 3025141-2023-00629 and 3025141-2023-00631 for the other devices involved in this event.

• Brand Name: T8 STICK FIT HEXALOBE DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 18102958
• MDR Text Key: 327767866
• Report Number: 3025141-2023-00630
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 80-0759
• Device Catalogue Number: 80-0759
• Device Lot Number: 540134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Race: Asian