MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH K-WIRE Ø2 L280 SST; GUIDE WIRE

Catalog Number 292.210.01

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part has yet to be received.Product investigation has not been completed; no conclusion could be drawn, as no product was received.The 510k: device is not distributed in the united states, but is similar to device marketed in the usa.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

It was reported that pre-operatively it was noticed that one k-wire was twisted.There was no patient consequence.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).This report is for a k-wire.

Manufacturer Narrative

A device history record review was performed for the subject device: part number: 292.210.01.Synthes lot number: 9885403.Release to warehouse date: 21.March 2016.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.An investigation was performed for the subject device: our investigation shows that the guide wire is slightly deformed and damaged approx.40 mm from the tip.Furthermore, there are different nicks and striation signs on the surface.Unfortunately, we are not able to determine the exact cause.Due to the deformation signs, we assume that the k-wire did most likely came in contact with an unknown metallic object during its use.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.

Manufacturer Narrative

Additional product code: hty.Subject device has been received and is currently in the evaluation process.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: K-WIRE Ø2 L280 SST
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7337788
• MDR Text Key: 102345368
• Report Number: 8030965-2018-52046
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319752
• UDI-Public: (01)07611819319752(10)9885403
• Combination Product (y/n): N
• PMA/PMN Number: PREAD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.210.01
• Device Lot Number: 9885403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR