MAUDE Adverse Event Report: SYNTHES BALSTHAL 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL

Catalog Number 292.620

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product code is hty.Device is an instrument and is not implanted/explanted.(b)(6).A manufacturing evaluation including a device history record review were performed for the subject device.The reported guide wire was received by synthes with a broken tip as complained.No fragments are missing.A device history record (dhr) review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Dates of manufacture: aug 17, 2016.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformance reports (ncrs) were generated during the production of the subject device.Raw material lot 19309 (round 1.25mm) was used to produce this lot as documented in the dhr.Measurable dimensions were checked and found to be within the specifications.No manufactured related issue could be identified.A root cause could not be definitively determined however visual inspection shows that the thread at the tip of the device is badly damaged as result of strong contact with hard material.This complaint is confirmed as the tip is broken as complained but is invalid from manufacturing procedure.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery the patient¿s bone substance was good resulting in the guide wire not moving smoothly.Moreover, the direction was not fixed.The surgeon repeated insertion and removal several times then the guide wire was broken.All the broken parts were removed from patient¿s body and the surgery was completed successfully.The surgery was extended for 20 minutes due to the reported event.This report is 1 of 1 for (b)(4).

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6553201
• MDR Text Key: 74706958
• Report Number: 3009450863-2017-10011
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841(10)L100899
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620
• Device Lot Number: L100899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR