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

Catalog Number 292.620S

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

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient exact age and date of birth are unknown.The patient is reportedly in their 60¿s.Additional device product code is hty.(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: dec 5, 2016.Expiration date: nov 1, 2026.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 to treat a radius diaphysis fracture on (b)(6) 2017 after the insertion of the guide wire, the surgeon wanted to change the direction and when he removed the guide wire, it was discovered that the guide wire was broken.Because the broken tip remained inside the patient, the surgeon pushed the tip using another guide wire and was able to extract the fragment from the opposite side.Another guide wire was used and the surgery was completed.The surgery was successfully completed with a 15 minute delay.Additional medical intervention was not needed.The patient was reportedly doing well postoperatively.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for non-sterile part# 292.620, lot# l211237.Manufacturing location: (b)(4), manufacturing date: nov 22, 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation has been completed.It was confirmed that the tip of the guide wire was broken as complained.The broken fragment was not received for investigation; therefore the shape of the threaded tip could not be measured.We have measured the dimension of the shaft of the broken guide wire with measuring device and relevant drawings were reviewed.The result of 1.24mm meets the specification.No product related issue could be identified.The root cause of the reported problem could not be identified.It was confirmed by the reporter that the missing tip was removed.However, it was not sent for 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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6405016
• MDR Text Key: 69949593
• Report Number: 3000270450-2017-10090
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMED
• 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,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Device Lot Number: L221168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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