MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE; SCREWDRIVERS

Catalog Number	03.607.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tip of the screwdriver is broken off as complained.Almost the whole bihexagonal tip is broken off and was not returned for investigation.The fracture angle is oblique.Besides, the instrument presents normal signs of use.Dimensional inspection cannot be performed due to the damage incurred.The complaint condition is confirmed as the tip of the screwdriver is broken.This production lot (3335962) was manufactured in march 2010 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criteria's.A definitive root cause for the screwdriver breaking could not be determined based on the provided information.The oblique fracture angle suggests that off-axis force has been applied.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 03.607.001, lot: 3335962, manufacturing site: (b)(4), release to warehouse date: 11 march 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the tightening end of screwdriver snapped off.This case was reported by the loan kit technician during loan kit inspection.No further information can be obtained as the case was not reported by the customer.This report is for one (1) 3.0mm bihexagonal screwdriver with t-handle.This is report 1 of 1 for (b)(4).

• Brand Name: 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9151893
• Report Number: 8030965-2019-68971
• Device Sequence Number: 16600399
• Product Code: HXX
• UDI-Device Identifier: 07611819185371
• UDI-Public: (01)07611819185371
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 03.607.001
• Device Lot Number: 3335962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1