MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HANDLE F/SCREWDRIVER SHAFT 2.5 HEXAGONAL/STARDRIVE T15; SCREWDRIVERS

Catalog Number 03.400.111

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review / investigation.Occupation: synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the driver was unable to be remove, no further information is available.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: HANDLE F/SCREWDRIVER SHAFT 2.5 HEXAGONAL/STARDRIVE T15
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9147162
• MDR Text Key: 163188563
• Report Number: 8030965-2019-68941
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819816831
• UDI-Public: (01)07611819816831
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.400.111
• Device Lot Number: 8191715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1