MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDEWIRE Ø1.1 L150 SST

Catalog Number	292.623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2018
Type of Reportable Event	Malfunction
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 synthes europe reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6) 2018, while drilling for insertion of a 3.5mm cannulated screw with the 2.7mm drill bit on the 1.1mm non-threaded guide wire, the guide wire split.A fragment of the broken wire remains in the patient.This report is for one (1) 1.1mm non-threaded guide wire.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that the guide wire was left in the patient¿s bone, not in joint space.
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.Corrected data: udi complainant part is not expected to be returned for manufacturer review/investigation.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: GUIDEWIRE Ø1.1 L150 SST
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7423372
• Report Number: 8030965-2018-53008
• Device Sequence Number: 13462528
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2018

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: 292.623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1