MAUDE Adverse Event Report: SYNTHES HAGENDORF 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE; SCREWDRIVERS

Catalog Number	314.132
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 314.132, lot # l286746: manufacturing location: (b)(4), manufacturing date: 22.Mar.2017: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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
It was reported that the hex tip of the driver is stripped.This was discovered during a routine inspection of instruments sets at a facility.No patient involvement.This report is for one (1) 3.0mm hexagonal screwdriver with t-handle this is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, device history records review and drawing review were performed as part of this investigation.The returned devices were examined and the drive tip of the screwdriver was found to be twisted.The 3.0mm hexagonal driver (314.132) is a component of the uss variable axis screw (vas) system for posterior fixation of the lumbar spine and is utilized for screw insertion.The returned device was examined and the complaint condition was able to be confirmed as the distal tip was found to be twisted.The driver dimensions and material characteristics were utilized to calculate a yield strength of approximately 4.2 nm.He failure mode of a twisted tip is likely the result of the application of torque in excess of 4.2nm leading to deformation; hard patient bone or inadequate pedicle preparation may have contributed to the complaint conditions.Relevant drawings for the returned device were reviewed.A dimensional analysis is not applicable due to observed post-manufacturing damage.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition was unable to be replicated due to post-manufacturing damage.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: 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6880885
• Report Number: 3003875359-2017-10470
• Device Sequence Number: 13784241
• Product Code: HXX
• UDI-Device Identifier: 10705034769004
• UDI-Public: (01)10705034769004(10)L286746
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/29/2017

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: 314.132
• Device Lot Number: L286746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1