MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH SCRDRIVER 4.5/5 T25 W/GROOVE L252; SCREWDRIVERS

Catalog Number	314.164
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Device is an instrument and is not implanted/explanted.Therapy date of concomitant device is unknown.(b)(6).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 synthes europe reports an event in (b)(6) as follows: it was reported that screw recesses damaged when removing two screws.No patient consequence.This is all information we do have so far.Concomitant parts reported: 2x unknown screws, part unknown, lot unknown.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 314.164, lot # l234628: manufacturing location: hägendorf, release to warehouse date: 27.Dec.2016: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A manufacturing investigation was performed.Received one (1) article of scrdriver 4.5/5 t25 w/groove l252 (part # 314.164, lot # l234628) for manufacturing investigation.The article is in a used condition.The screwdriver tip is twisted.During manufacturing investigation, the hardness and outer diameter of the stardrive t25 screwdriver tip has been measured.The actual test results are within specification.The deformation of the screwdriver tip is caused by mechanical overloading during use.No production failure was found during investigation.No manufacturing related issue was identified and/or confirmed.Date device returned to manufacturer.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: SCRDRIVER 4.5/5 T25 W/GROOVE L252
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• MDR Report Key: 7068664
• Report Number: 8030965-2017-50161
• Device Sequence Number: 127073
• Product Code: HXX
• UDI-Device Identifier: 07611819159471
• UDI-Public: (01)07611819159471(10)L234628
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 11/01/2017

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: 314.164
• Device Lot Number: L234628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1