MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG; SCREWDRIVERS

Catalog Number	03.632.074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019 the patient underwent l2-4 revision posterior lumbar fusion (plf) surgery due to an insecure construct.The left l2 locking cap had come out of the screw head and was floating in soft tissue, thus revision surgery was needed.Primary implant date was (b)(6) 2012.During the revision procedure the green t handle shaft broke off when trying to loosen a locking cap on the right l2 screw.The cap was cold welded to the screw head and unable to be removed so the rod was cut and then the surgeon was able to use a nibbler to spin the screw out.There was ten (10) minutes surgical delay in the procedure.The revision procedure was successful.This report captures the intra-op event of the t-handle breakage, while related complaint (b)(4) captures the post-op event of the locking cap back out.This report is for one (1) t-handle t25 stardrive shaft f/matrix-long.This is report 1 of 2 for complaint (b)(4).

• Brand Name: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8951317
• Report Number: 8030965-2019-67885
• Device Sequence Number: 2129391
• Product Code: HXX
• UDI-Device Identifier: 07611819377301
• UDI-Public: (01)07611819377301
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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: 03.632.074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR