MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC; SCREWDRIVERS

Catalog Number	03.632.052
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient underwent a posterior instrumented fusion at l2-s1 on (b)(6) 2015.Patient was returned to surgery on (b)(6) 2018 for revision due to radiculopathy, narrowing foramen, and reduction of disc height.During the revision procedure, surgeon was attempting to torque off the matrix crosslink inner set screw but had difficulty as the tip of the locking stardriver screwdriver shaft t15 was worn, stripped, and had sheared off.Surgeon was unable to torque off one (1) set screw.Surgery was delayed approximately 10 minutes.No adverse effect to patient was reported.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device history record review: part # 03.632.052 synthes lot # 9807569, supplier lot # 9807569, release to warehouse date: 18 sep 2015, manufactured by synthes monument.No ncr¿s were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device is not available for investigation; device was discarded.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Additional information received: it was confirmed that the screw was that re-positioned during the procedure on (b)(6) 2018 was not a synthes product.The revision procedure dated (b)(6) 2016 also did not involve a synthes product.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: LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7270772
• Report Number: 8030965-2018-51112
• Device Sequence Number: 16645778
• Product Code: HXX
• UDI-Device Identifier: 07611819379541
• UDI-Public: (01)07611819379541(10)9807569
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2018

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: 03.632.052
• Device Lot Number: 9807569
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 04/05/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 03/07/2018; 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1