MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.1MM NON-THREADED GUIDE WIRE 150MM

Catalog Number	292.623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age, date of birth, and weight not available for reporting.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.Without a lot number the device history records review could not be completed.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 (b)(4) europe reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6) 2018, surgeon attempted to place the 1.1mm non-threaded guide wire and the tip of the needle broke.The needle tip remains embedded in patient¿s bone with no possibility of removal, as doing so could cause damage to the patient.This report is for one (1) 1.1mm non-threaded guide wire.This is report 1 of 1 for (b)(4).

• Brand Name: 1.1MM NON-THREADED GUIDE WIRE 150MM
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7422181
• Report Number: 8030965-2018-52990
• Device Sequence Number: 13591949
• Product Code: FZX
• UDI-Device Identifier: 10886982180735
• UDI-Public: (01)10886982180735(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 292.623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention