MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T8 105MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Catalog Number 314.467

Device Problems Failure To Adhere Or Bond (1031); Device Slipped (1584)

Patient Problem Sedation (2368)

Event Date 03/23/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon was unable to lock the screws into the variable angle ¿ locking compression plate (va-lcp) with the associated screwdriver during a procedure on (b)(6) 2015.The screw head was reportedly worn by the screwdriver tip, which did not hold the screws properly for rotation.The surgeon was not able to fully grasp the screw head with the screwdriver shaft.No backup driver was available, so the surgeon had to use the one in question to attempt to tighten all six (6) screws.Gauze was placed between the driver and the screw heads in an attempt to facilitate a better hold, but that effort was not successful.The surgeon then cut off the tip of the driver off (because it was twisted) and attempted to secure the lock on the screws.This, too, was not successful.The surgeon closed the wound, but was unsure if the screws were properly locked.A thirty (30) minute delay in procedure time was recorded.This report is 3 of 5 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Per facility, complainant part is expected for return, but has yet to be received for review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.A product investigation was completed: the tip of the screwdriver is completely worn out.The edges are rounded and plastically deformed due to heavily overloading situation during use.It is likely that the tip was not properly inserted into the screw head while use.Therefore the edges were damaged when torsional force was applied.Visual inspection as well as dhr reviews shows no product fault.Mishandling while in use could be identified as most probably root cause.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Lot number was obtained upon receipt of subject device.Subject device was received on april 30, 2015.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 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.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.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: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4656491
• MDR Text Key: 5732205
• Report Number: 2520274-2015-12486
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.467
• Device Lot Number: 7736555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2015; 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 54