MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T8 105MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 314.467

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 314.467, synthes lot 7799893: release to warehouse date: march 17, 2015.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product investigation was completed: this complaint is confirmed.The returned instrument was examined and the complaint condition was able to be confirmed as the distal tip of the driver is twisted approximately 20 degrees in the direction of resistance met during screw insertion.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the tip of the returned device is already twisted due to post-manufacturing damage.No definitive root cause was able to be determined however the failure mode is typically associated with the application of force which exceeded the plastic deformation limit of the screwdriver shaft.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The t8 stardrive screwdriver shaft (314.467) is a common trauma instrument, noted in 30 system technique guides including: 2.4mm va lcp distal radius, compact distal radius and modular clavicle plate.In each instance the instrument is utilized for screw insertion/removal.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No product design issues or discrepancies were observed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during set-up for an in-service training, the consultant noticed the screwdriver had a twisted tip.There was nothing broken off the driver, and there was no reported patient or procedure involvement.It is unknown when the tip became twisted.This is report 1 of 1 for com-(b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8 105MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6206351
• MDR Text Key: 63330342
• Report Number: 1719045-2016-10947
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10886982188922
• UDI-Public: (01)10886982188922(10)7799893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 314.467
• Device Lot Number: 7799893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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