MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM; SCREWDRIVERS

Catalog Number	03.019.020
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
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 on (b)(6) 2019 the patient underwent open reduction internal fixation surgery for proximal humerus fracture with the locking screw and the stardrive screwdriver in question.During the surgery, the surgeon replaced a locking screw (20mm) with the screw (22mm) because the 20mm screw was short.The screw didn¿t seem to stick in the bone firmly so the surgeon pushed the screw with the screwdriver, but the screw backed out with the screwdriver.There was no surgical delay.The surgeon commented that the bone quality might be bad.This report is for one stardrive screwdriver t25 w/ coupling for 03.019.019/330mm.This is report 2 of 2 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9577255
• Report Number: 8030965-2020-00251
• Device Sequence Number: 11479706
• Product Code: HXX
• UDI-Device Identifier: 07611819427204
• UDI-Public: (01)07611819427204
• 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): 12/17/2019

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: 03.019.020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1