MAUDE Adverse Event Report: SYNTHES BALSTHAL 2.8MM THREADED GUIDE WIRE-TROCAR POINT 300MM; APPLIANCES, FIXATION, NAIL, BLD, PL COMBO, MULTI COMP, METAL COMP

Catalog Number 292.680

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

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier and weight are not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital contact telephone: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Manufacturing location: (b)(4).Manufacturing date: 28.Dec.2015.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported during a pediatric orthopedic procedure for epiphysiolysis, while surgeon was performing wicking the guide wire broke into the patient's bone.The proximal portion of the guide wire was removed but the distal portion remains embedded in patient's femoral neck.A second guide wire was used in another direction to complete the procedure.No surgery to remove the broken guide wire is planned.This report is for one (1) 2.8mm threaded guide wire.This is report 1 of 1 for (b)(4).

• Brand Name: 2.8MM THREADED GUIDE WIRE-TROCAR POINT 300MM
• Type of Device: APPLIANCES, FIXATION, NAIL, BLD, PL COMBO, MULTI COMP, METAL COMP
• 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: 6681523
• MDR Text Key: 79143051
• Report Number: 3009450863-2017-10019
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 07611819065208
• UDI-Public: (01)07611819065208(10)9785127
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PREAD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.680
• Device Lot Number: 9785127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16 YR