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

Catalog Number	03.130.020
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 the patient underwent an open reduction internal fixation (orif) with the variable angle (va) hand system for a second metatarsal bone fracture on (b)(6) 2019.During the procedure, the surgeon tried to insert a screw using the stardrive screwdriver shaft and the driver shaft detached from the screw.The surgeon commented that he wanted to have a sleeve to support the screw since it is easily detached from the driver shaft.The procedure was successfully completed with no adverse consequence to the patient.Concomitant devices: screw (part: unknown, lot: unknown, quantity: 1).This report is for a stardrive screwdriver shaft.This is report 1 of 1 for (b)(4).

• Brand Name: STARDRIVE SCRWDRVR SHFT/T6 50MM/SELF-RETAINING/HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8286341
• Report Number: 8030965-2019-60458
• Device Sequence Number: 11249510
• Product Code: HXX
• UDI-Device Identifier: 07611819682979
• UDI-Public: (01)07611819682979
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/09/2019

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: 01/09/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1