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

Catalog Number 314.467

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Issue was discovered on (b)(6) 2016, but it unknown when the damage occurred.Part 314.467, lot 7736544: release to warehouse date: september 03, 2014.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 noticed that during surgery on (b)(6) 2016 for a left wrist fusion, the distal end of the stardrive screwdriver was found to be twisted/deformed and would not hold the end of the screw.The screwdriver was never used in the surgery and another screwdriver was readily available.The surgery was reported to have been successfully completed without delay and the patient stable.Concomitant device: screw (part unknown, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device.The returned instrument was examined and the complaint condition was able to be confirmed as the distal tip of the driver was found to be worn with deformed distal lobes and twisted.No definitive root cause was able to be determined however the failure mode is typically associated with wear and tear and/or rough handling (device mfg sep-2014).No complaint condition was unable to be replicated due to post-manufacturing damage.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.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.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 6140043
• MDR Text Key: 61308685
• Report Number: 1719045-2016-10873
• Device Sequence Number: 1
• Product Code: KWQ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.467
• Device Lot Number: 7736544
• Other Device ID Number: (01)10886982188922(10)7736544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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
• Treatment: 1 UNKNOWN SCREW