MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC; SCREWDRIVER

Catalog Number	03.130.020
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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)(4) as follows: it was reported that on an unknown date, that the screw drivers in their sets are not capturing the screws correctly as they have become worn with use.2 x 03.130.010 screwdriver shaft stardrive® 1.3/1.5, t4, self-holding, for hexagonal coupling.2 x 03.130.020 screwdriver shaft stardrive® 2.0, t6, self-holding, for hexagonal couplin.No further action is required and no harm was done to any patients.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) stardrive scrwdrvr shft/t6 50mm/self-retaining/hxc.This is report 4 of 4 for (b)(4).

• Brand Name: STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9128991
• Report Number: 8030965-2019-68779
• Device Sequence Number: 2477429
• Product Code: HXX
• UDI-Device Identifier: 07611819682979
• UDI-Public: (01)07611819682979
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/04/2019

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: 03.130.020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/27/2019
• Patient Sequence Number: 1