MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCRDRIVER T40 W/SPHERIC-HEAD CANN L277; SCREWDRIVER

Catalog Number	03.010.520
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device history records review was conducted.The report indicates that the: dhr review for: part no.: 03.010.520, lot no.: 9642376.Manufacturing location: (b)(4).Release to warehouse date: 14.Dec.2015.No 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.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 before the surgery it was found there was blood or rust like stain on the screwdriver.The screwdriver in question was not used in the surgery.This complaint involves 1 part.This report is 1 of 1 for (b)(4).
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.Date entered in initial report was 2/23/2018.Correct date should be 2/22/2018.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 T40 W/SPHERIC-HEAD CANN L277
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7363383
• Report Number: 8030965-2018-52326
• Device Sequence Number: 1233089
• Product Code: HXX
• UDI-Device Identifier: 07611819499164
• UDI-Public: (01)07611819499164(10)9642376
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: 03.010.520
• Device Lot Number: 9642376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1