MAUDE Adverse Event Report: SYNTHES USA 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL, PIN, FIXATION, THREADED

Catalog Number 292.65

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: jdw.(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Subject device has not been received.Without a lot number, the device history record review and 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.

Event Description

It was reported that during a procedure on (b)(6) 2015 the paint was chipping on a single use 2.0mm threaded guide wire; the surgeon was able to continue to use the guide wire.The chipped paint fragments fell on the floor and did not reach the patient.There is no report of the device breaking.This surgery was successfully completed with no additional intervention or patient harm and no surgical delay.Patient status and outcome were successfully completed.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Facility/hospital contact phone number provided.Correct to product problem/replaced, updated.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: 2.0MM THREADED GUIDE WIRE 230MM
• Type of Device: WIRE, SURGICAL, PIN, FIXATION, THREADED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5315337
• MDR Text Key: 34017063
• Report Number: 2520274-2015-18010
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREADMNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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