MAUDE Adverse Event Report: SYNTHES BALSTHAL 1.6MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL

Catalog Number 292.720

Device Problems Bent (1059); Mechanical Jam (2983)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.A manufacturing investigation was performed for the subject device (1.6mm threaded guide wire 150mm, part number 292.720, lot number 9446577).The subject device was received with the associated cannulated screw (please see related medwatch reports (b)(4)).The devices were received with the cannulated screw completely stuck on the guide wire.Both the cannulated screw and the guide wire are bent.The relevant outer diameter of the visible portions of the guide wire near the top and bottom of the cannulated screw were checked and was found to be 1.58mm, which is within the specification of 1.6mm 0/-0.1.The relevant inner diameter of the cannulated screw could not be checked as the screw is stuck on the wire and a removal with destructive force would damage the inner diameter.However, it was apparently possible to advance the screw approximately 120mm over the wire before it did got stuck without any issues as there are no stress marks at the upper part of the visible wire visible.Based on this it can be assumed that the inner diameter of the screw did not contribute to this occurrence.A device history record review was performed for the subject device lot.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.Based on the provided information, the exact root cause could not be determined.The overall appearance with the bent cannulated screw on the bent guide wire, along with the peeled off thread core in relation to the bending position, could be an indication that the guide wire was bent after the insertion which would have made correct insertion of the cannulated screw impossible.As previously reported, manufacturing documents were reviewed and no deviations regarding dimensions or materials were found.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 reported an event in (b)(6) as follows: it was reported that during a surgical procedure on (b)(6) 2016 to treat an ankle fracture, the guide wire and the cannulated screw became stuck together after the screw was inserted.The surgeon initially inserted the reported screw over the guide wire during placement.When the surgeon attempted to remove the guide wire, it was discovered that the two devices could not be separated and the surgeon had to remove the screw with the guide wire stuck inside it from the patient's bone.Upon examination of the complained screw, it was noted that the tip of the screw and threads along the shaft appeared to be damaged.Some of the thread material had appeared to have "chiipped away".An intraoperative x-ray was taken and it was reported that screw thread fragments were visible in the patient's bone.These fragments were not removed.The surgeon was able to complete the procedure using a different screw.The surgery was delayed 10 minutes due to the reported event; however, was completed without any further complications.Based upon the initially reported information, the guide wire was not determined to be reportable and an initial report was submitted for the cannulated screw only.Both the reported cannulated screw and guide wire were returned to synthes for investigation.Based on the received condition of the guide wire and the results of the investigation, the event in relation to the guide wire was re-assessed on (b)(6) 2016 and determined to be a reportable malfunction.This report is 2 of 2 for (b)(4).

• Brand Name: 1.6MM 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5503851
• MDR Text Key: 40420753
• Report Number: 3009450863-2016-10007
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: PPREAM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.720
• Device Lot Number: 9446577
• Other Device ID Number: (01)07611819039698(10)9446577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1