MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH K-WIRE Ø3 THREAD-TIP L150/15 SST; CERCLAGE FIXATION

Catalog Number 292.820.01

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): 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 that during an unknown procedure on an unknown date, the tip of the k-wire snapped off.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.This is report 1 of 1 for complaint (b)(4).

• Brand Name: K-WIRE Ø3 THREAD-TIP L150/15 SST
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7691094
• MDR Text Key: 114558797
• Report Number: 8030965-2018-55050
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819320024
• UDI-Public: (01)07611819320024
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/21/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 292.820.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1