MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T8105MM; 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 was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product or any subcomponents that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 instrument inspection in the central sterile processing department, the tip of screw driver shaft was found twisted and over-torqued.There is no known patient or surgical involvement.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Product investigation summary: one (1) t8 stardrive screwdriver shaft (part: 314.467 / lot: 9981812) was returned with a complaint stating that the tip was found in sterile processing twisted and over torqued.The complaint was able to be confirmed as the tip of the screwdriver was indeed twisted (approximately 30 degrees) in the direction of screw insertion.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection under 5x magnification and drawing review were performed as part of this investigation.No definitive root cause was able to be determined; however, the failure mode is consistent with the application of excessive torque.The design is adequate for its intended use when used and maintained as recommended.The t8 stardrive screwdriver shaft 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.Based on the complaint description, a specific system was unable to be identified.In the lcp distal radius system, the driver is available for use in final tightening when utilized in conjunction with a 0.8nm torque limiting attachment.The technique guide notes that use of the torque limiting attachment (tla) is mandatory when inserting locking screws into variable angle locking holes to ensure the adequate torque is applied.Final locking must be done manually using the tla.The relevant drawings for the returned instruments were reviewed (both from the time of manufacture and present revision): top-level and tip profile.The design, materials, and finishing processes were found to be appropriate for the intended use of the device.No definitive root cause was able to be determined; however the failure mode is consistent with the application of excessive torque.Device 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.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8105MM
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5765003
• MDR Text Key: 48643223
• Report Number: 1719045-2016-10526
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK152239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• 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: 9981812
• Other Device ID Number: (01)10886982188922(10)9981812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• 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