MAUDE Adverse Event Report: SYNTHES HAGENDORF SCREWDRIVER BIHEX 3 W/T-HANDLE; SCREWDRIVERS

Catalog Number	03.607.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that: manufacturing site: (b)(4).Manufacturing date: 13.Feb.2015.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that 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
Device report from synthes on an event in (b)(6) as follows: it was reported that one tip broken off and one tip twisted.This occured intraoperatively.No further information available at the moment.The issue happened during a revision case where screws were removed and also added.The screw was inserted into the dense bone and got stuck and could not be inserted or removed.The patient is doing well and the case was completed successfully.The surgery was not prolonged and no other medical intervention was required.There is no allegation against the screw.The problem was with the screwdrivers.This complaint involves 1 part.Concomitant reported part: unknown screws.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A customer quality investigation was performed for the subject device: the manufacturing documents were reviewed and no complaint related issues were found.The complaint is confirmed as on the received picture one broken and on twisted screwdriver is visible.Also, it visible that the breakage of the broken screwdriver occurred during the tightening of a screw as it was twisted clockwise before it broke.The twisting of the twisted screwdriver occurred during the loosening of a screw as it is twisted counter-clockwise.These findings are consistent with the complaint description.The twisted condition of both screwdrivers is an indication of a mechanical overload during use.However, the products were not returned, therefore no investigation is possible and no root cause can be defined.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information or material is made available, the investigation will be updated as applicable.The twisted condition of both screwdrivers is an indication of a mechanical overload during use.However, the products were not returned, therefore no investigation is possible and no root cause can be defined.Device 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: SCREWDRIVER BIHEX 3 W/T-HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6869729
• Report Number: 3003875359-2017-10459
• Device Sequence Number: 691750
• Product Code: HXX
• UDI-Device Identifier: 07611819185371
• UDI-Public: (01)07611819185371(10)9333192
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 03.607.001
• Device Lot Number: 9333192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1