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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent an open reduction internal fixation surgery for proximal humerus fracture with the screwdriver in question.During the screw insertion the surgeon had difficulty inserting the screw.The surgeon checked the tip of the screwdriver and he found that it was worn.There was no surgical delay.Concomitant medical product: unknown screw (part# unknown, lot# unknown, quantity# 1).This report is for one stardrive screwdriver t25 w/ coupling for 03.019.019/330mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
Patient's outcome is reported as stable.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the distal tip (stardrive) of the returned screwdriver is worn as complained.This part was manufactured in april 2013 and was almost 7 years in use.The shaft and the handle are otherwise in good condition.Summary: the complaint condition is confirmed as the screwdriver is worn.After a visual inspection, 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.019.020, lot: 8318590, manufacturing site: hägendorf, release to warehouse date: 12.Apr.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 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: 9707852
• Report Number: 8030965-2020-01115
• Device Sequence Number: 3381573
• 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,Followup
• Report Date (Section B): 01/22/2020

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: 03.019.020
• Device Lot Number: 8318590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1