MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CROSS PINNED HEX SCREWDRIVER SHAFT/QC; SCREWDRIVERS

Catalog Number	03.614.039
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
Part # 03.614.039 synthes lot # is10424.Supplier lot # is10424.Release to warehouse date: 20 jan 2010.Supplier: (b)(4).No ncr's 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.Visual inspection: the device is in a used condition, there are wear mark at the coupling piece and the shaft.The hexagon is discolored and is worn at the forefront.Investigation conclusion: the complaint is confirmed to the wear at the forefront of the hexagon.After a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 (b)(6) reports an event as follows: it was reported that on an unknown date that the screwdriver was faulty.This report is for one (1) cross pinned hex screwdriver shaft/qc.This is report 1 of 1 for (b)(4).

• Brand Name: CROSS PINNED HEX SCREWDRIVER SHAFT/QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9917810
• Report Number: 8030965-2020-02590
• Device Sequence Number: 754446
• Product Code: HXX
• UDI-Device Identifier: 07611819310612
• UDI-Public: (01)07611819310612
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 03.614.039
• Device Lot Number: IS10424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1