MAUDE Adverse Event Report: ACUMED LLC 1.5MM HEX DRIVER TIP, LOCKING GROOVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - DRIVER

Model Number 80-0728

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Information (3190)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

A visual examination under magnification of the returned driver was performed.Torsional fracture pattern was found at transition of hex into radius.A torsional fracture pattern likely indicates an excessive twisting load (torsion).Additional mdrs associated with this event: 3025141-2018-00245: screw.

Event Description

While implanting an aculoc 2 plate, the tip of the driver broke off in a locking screw.The tip could not be removed and was left implanted in the head of the screw.

• Brand Name: 1.5MM HEX DRIVER TIP, LOCKING GROOVE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - DRIVER
• 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: micki lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7630510
• MDR Text Key: 112062952
• Report Number: 3025141-2018-00244
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 80-0728
• Device Catalogue Number: 80-0728
• Device Lot Number: 298044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2013
• 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