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

Catalog Number 292.620S

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2014

Event Type  malfunction  

Event Description

Device report from (b)(6) reports the following: during guide wire insertion from the medial malleolus side, the surgeon performed properly according to the technical guide.However, the tip of the wire broke.The surgeon finished the surgery with a delay of 20 minutes, leaving the broken piece of the wire into the patient's bone.This is report 1 of 1 for complaint com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).No nonconformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an investigation summary was performed; the investigation shows that the guide wire is broken off at the threaded area.The broken off fragment is missing.Also we found striations signs on the surface.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the received information we are not able to determine the exact cause of this complaint because no detailed information about the event is available.We can only assume that the breakage was caused due to a mechanical overloading situation during use.The complaint relevant dimensions could not be checked due to the damage conditions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 BALSTHAL; dornacherstrasse 20; balsthal PA 19380 CH4; SZ 19380 CH47
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4428661
• MDR Text Key: 5171089
• Report Number: 2520274-2015-10427
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/25/2014

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 Expiration Date: 08/01/2023
• Device Catalogue Number: 292.620S
• Device Lot Number: 8579759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 01/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2015; 03/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR