MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS; SCREWDRIVERS

Catalog Number	03.610.602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Hospital contact number was not provided.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, during the procedure, the customer opened the set and checked the instruments, went to load a screw and one of the spokes that attaches to the screw snapped off.There was no impact to the patient.They had to open and use a different kit.Concomitant device reported: screws (part# unknown, lot# unknown, quantity unknown).This report is for one (1) self-retaining screwdriver for quick lock screws.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part: 03.610.602.Lot: 9085066.Manufacturing site: (b)(4).Release to warehouse date: 29.Sep.2014 the device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.The manufacturing documents were reviewed and no complaint related issues were found.The investigation could not be completed; no conclusion could be drawn, as no product was received.Corrected data: date of event is not known.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
It was noted during a procedure on (b)(6) 2018 that the self-retaining screwdriver was broken.Device was not used during that procedure.It is not known when the fragment was broken off.

• Brand Name: SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7614002
• Report Number: 8030965-2018-54418
• Device Sequence Number: 2221470
• Product Code: HXX
• UDI-Device Identifier: 07611819895508
• UDI-Public: (01)07611819895508
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 03.610.602
• Device Lot Number: 9085066
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1