MAUDE Adverse Event Report: ACERO PRECISION THREADED LOCKING DRIVER; LOCKING SCREWDRIVER

Catalog Number 905-1011

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

A threaded locking driver ((b)(4); lot ap15613) broke during a 1-level lumbar case on (b)(6) 2015.Specifically the screwdriver tip broke during final locking of the assembly.The procedure continued without incident.The fractured segment was left in the cap of the screw.

Manufacturer Narrative

The device was returned for evaluation.Manufacturing device history records (dhr) were reviewed and the process & inspection plan shows all 65 received pieces of p/n (b)(4) lot ap15613 being accepted with no rejected pieces.All records indicate the product was manufactured to specifications.The returned device is missing the distal-most portion of the t25 driver feature, with the fracture plane being slightly askew with respect to a normal plane relative to the device's center-line axis.The remaining portion of the t25 driver shows a counter-clockwise torsional deformation in the remaining lobes, consistent with failure during clockwise torsional load application (tightening).In order for a t25 driver to fail in such a manner, loads greatly in excess of the recommended 7.4nm must have been applied.Per the approved surgical technique, the final tightening instrumentation was tested using a digital torque meter.All results were within specifications, eliminating a torque handle malfunction as the root cause of the driver breakage.Per the surgical technique, the driver tip should be fully inserted into the t25 recess in the locking cap before attempting final tightening maneuvers.The damage displayed by the returned device cap before attempting final tightening maneuver was performed with the t25 tip improperly engaged indicates that an "off-axis" tightening maneuver was performed with the t25 tip improperly engaged within the locking cap.It is likely that a torque limiting handle was not utilized in conjunction with a counter-torque, allowing the "off-axis" tightening as well as an over-application of torque.Due to the above findings, it must be concluded that an improper surgical technique was utilized.

• Brand Name: THREADED LOCKING DRIVER
• Type of Device: LOCKING SCREWDRIVER
• Manufacturer (Section D): ACERO PRECISION; west chester PA
• Manufacturer Contact: claudia hill ; 5129 w chester pike; newtown square, PA 19073 ; 6103554156
• MDR Report Key: 4475478
• MDR Text Key: 16990006
• Report Number: 3009049161-2015-00001
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 905-1011
• Device Lot Number: AP15613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR