MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE; SCREWDRIVERS

Catalog Number	03.607.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during a spinal fusion for pelvic fracture on (b)(6) 2019 a screwdriver broke.While the surgeon was drilling the iliac bone with the screwdriver, the torque became excessively larger due to the hard bone quality, and the screwdriver¿s tip broke off.It was confirmed by x-rays that no fragment left in the patient's body.The surgery was completed successfully with less than 30-minute surgical delay.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the complete double hexagon tip is broken of from the received bihexagonal screwdriver.The fragment was returned, it is strongly twisted in counterclockwise direction and there is a crack visible at the place where the fracture started, in addition are some flanks of the double hexagon flattened on the opposite of the crack initiation zone.The handle is in a used condition with slight scratches and nicks all over.The other relevant dimensions cannot be verfied as the breakage occurred at the crossover from the double hexagon to the shaft and due the deformation of the fragment.The complaint is confirmed as the tip of the bihexagonal screwdriver is broken off as complained.During the performed evaluation no manufacturing related issue could be detected, the screwdriver was manufactured according to the specification.The screwdriver was strongly twisted before it broke, which indicates that it was exposed to very high torsional loads.Also we found that some flanks of the double hexagon flattened on the opposite of the crack initiation zone, this indicates that the device was exposed to lateral stress before it broke.Based on that it can be assumed that too much applied torque in combination with high lateral stress caused the breakage of the screwdriver.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part #: 03.607.001 , lot #: 9890648 , manufacturing site: hägendorf, release to warehouse date: 10.May 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 BIHEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8879524
• Report Number: 8030965-2019-67067
• Device Sequence Number: 18892740
• Product Code: HXX
• UDI-Device Identifier: 07611819185371
• UDI-Public: (01)07611819185371
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/12/2019

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: 03.607.001
• Device Lot Number: 9890648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1