MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG; SCREWDRIVERS

Catalog Number	03.620.002
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: dhr review.Part number: 03.620.002.Synthes lot number: 5061633.Supplier lot number: n/a.Release to warehouse date: 03-mar-2006.Expiration date: n/a.Manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the stardrive screwdriver shaft was stripped during an anterior lumbar interbody fusion (alif) procedure on (b)(6) 2017.Another screwdriver shaft from the set was used to complete the surgery with no delay.The procedure was successfully completed with great patient outcome.This complaint involves one device this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, drawing review and device history records review were performed as part of this investigation.The returned driver was examined and the distal tip was found to be slightly stripped with minor deformation of the distal driver lobes.No definitive root cause was able to be determined however the failure mode is typically associated with the application of torque when the driver tip is not fully engaged with the screw¿s drive recess and/or the application of excessive force.The compliant condition was unable to be replicated due to post-manufacturing damage.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.No dimensional analysis was able to be performed of the distal tip due to post-manufacturing damage.The stardrive screwdriver shaft t25/6mm hex ¿ long (03.620.002) is noted in multiple system technique guides including: pangea degenerative, cannulated pangea and antegra.In each system, the driver shaft is available for screw insertion and removal.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.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6973992
• Report Number: 1719045-2017-11110
• Device Sequence Number: 1196626
• Product Code: HXX
• UDI-Device Identifier: 10705034717425
• UDI-Public: (01)10705034717425(10)5061633
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.620.002
• Device Lot Number: 5061633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR