MAUDE Adverse Event Report: ACUMED, LLC 1.5MM CANN. QUICK RELEASE DRIVER TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number HT-0915

Device Problem Break (1069)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported during a routine hardware removal surgery the driver tip broke while the surgeon was trying to engage the screw to be explanted.The surgery was completed with backup drivers after a 2-5-minute delay.No other adverse patient consequences were reported.There are 2 related report numbers for this event and 3025141-2024-00260.

Manufacturer Narrative

The reported screw was not returned for evaluation.Additionally, manufacturing and inspection records could not be reviewed as the model number and batch lot number of the screw is unknown.However, the reported driver was returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.The 1.5mm cann.Quick release driver tip (part number ht-0915, batch number 238101) was returned for evaluation.The returned driver was examined under magnification and had physical batch number 238101.Torsional and oblique fracture patterns were identified at the transition from the radius to the hex tip.A torsional fracture pattern likely indicates an excessive twisting load about the driver's central axis, while an oblique fracture pattern likely indicates some side loading (bending), away from the driver's central axis, was also applied to the hex tip.Hex tip breakage may occur when excessive force is applied to the driver during use to overcome increased resistance.However, based on the information received and due to unknown surgical conditions, the root cause could not be determined.

• Brand Name: 1.5MM CANN. QUICK RELEASE DRIVER TIP
• 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: 18849802
• MDR Text Key: 337083501
• Report Number: 3025141-2024-00259
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT-0915
• Device Catalogue Number: HT-0915
• Device Lot Number: 238101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2010
• 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