MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH EXTRACTION SCREWDRIVER; SCREWDRIVERS

Catalog Number	352.311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Contact phone number was not provided.Without a lot number the device history records review could not be completed.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the apical portion of the screwdriver broke off inside the screw.It was not possible to extract the screw.Another screwdriver was used to complete the procedure.Concomitant product: screw (part/lot unknown, quantity 1).(b)(4).
Additional Manufacturer Narrative
A review of the device history records has been requested.: subject device has been received and is currently in the evaluation process.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.
Additional Manufacturer Narrative
Additional narrative: part 352.311, lot 7503750: release to warehouse date: 13january2014.Supplier: (b)(4).No non-conformance reports 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.A product investigation was completed: our investigation has shown that the received screwdriver is in a used condition.The driver 352.311 consists of three components: driver shaft including handle, inner shaft and an outer sleeve.The tip of the inner shaft was found broken.The broken part was not returned.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately, we only have limited information in the complaint description and cannot confirm how this happened.It is likely that an off-axis loading during attempted screw removal and/or the application of excessive force caused the tip breakage.Because of the damage and without broken part the complaint relevant dimensions cannot be checked for dimensional accuracy.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformances.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: EXTRACTION SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• MDR Report Key: 7154327
• Report Number: 8030965-2017-51011
• Device Sequence Number: 1863647
• Product Code: HXX
• UDI-Device Identifier: 07611819790735
• UDI-Public: (01)07611819790735(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 352.311
• Device Lot Number: 7503750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 02/07/2018; 02/26/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/16/2018; 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention