MAUDE Adverse Event Report: SYNTHES HAGENDORF STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM; SCREWDRIVERS

Catalog Number	03.114.009
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Phone number: (b)(6).Manufacturing location: (b)(4).Manufacturing date: july 31, 2014.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 the product that would contribute to this complaint condition.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 europe reports an event in (b)(6) as follows: it was reported that parts were detected as damaged during internal inspection of loaner kits.Reportedly there was no patient or procedure involvement.This report is for a screwdriver that was reportedly stripped.This is report 2 of 20 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
When the device was received by the manufacturer, it was noted that the device was stripped and the distal stardrive tip was bent/malformed.
Additional Manufacturer Narrative
Additional narrative: a product investigation was completed: a visual inspection under 5x magnification, functional test, drawing review, and dimensional analysis were performed as part of this investigation.A definitive root cause cannot be identified with the limited complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.The screwdriver was returned with the distal tip dented and pressed.It is unlikely that the design contributed to the complaint condition.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: STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6629419
• Report Number: 3003875359-2017-10282
• Device Sequence Number: 16406302
• Product Code: HXX
• UDI-Device Identifier: 10886982073037
• UDI-Public: (01)10886982073037(10)9006137
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2015

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: 03.114.009
• Device Lot Number: 9006137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 01/14/2016
• Supplement Date Received by Manufacturer: 06/23/2017; 07/19/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/18/2017; 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1