MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 130 DEGREE ANGLED GUIDE FOR 3.2MM GUIDE WIRES; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.168.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2020, the patient underwent the osteosynthesis surgery for femoral neck fractures.During the surgery, the surgeon had difficulties in placing the angled guide on the bone surface.It could not be placed in a stable state when he tried to insert a guide wire.The surgery was successfully completed with a thirty (30) minute delay.No further information is available.Concomitant device reported: unknown guidewire (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 130 degree angled guide for 3.2mm guide wires.This is report 1 of 1 for (b)(4).

• Brand Name: 130 DEGREE ANGLED GUIDE FOR 3.2MM GUIDE WIRES
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10321111
• Report Number: 8030965-2020-05255
• Device Sequence Number: 2964234
• Product Code: FZX
• UDI-Device Identifier: 07611819657274
• UDI-Public: (01)07611819657274
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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: 03.168.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING: GUIDE