MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM; PIN, FIXATION, THREADED

Catalog Number 292.790.01

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Additional procodes: dzl, mqn.Lot number is unknown.It is unknown if devices were implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address are unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported by the surgeon that during his recent procedure, three (3) 2.0mm k-wires bent very easily.There was no reported patient impact or delay.This has been a repeating occurrence and the surgeon is unsure of the total quantity of bent k-wires.This report is for a 2.0mm kirschner wire w/15mm thread-trocar point 150mm.This is report 2 of 3 for (b)(4).

Event Description

It was noted the procedure was completed successfully.

Manufacturer Narrative

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: 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7658886
• MDR Text Key: 113263179
• Report Number: 8030965-2018-54785
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819320017
• UDI-Public: (01)07611819320017
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.790.01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2018
• Patient Sequence Number: 1