MAUDE Adverse Event Report: SYNTHES ELMIRA 2.8MM GUIDE WIRE WITH FLUTES 450MM; PIN, FIXATION, SMOOTH

Catalog Number 02.207.001

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that: a review of the device history record of part number 02.207.001, lot number h144780 revealed no complaint related anomalies.The device history record shows this lot of 2.8mm guide wire with flutes was processed through the normal manufacturing and inspection operations.One part was scrapped at operation (b)(4) inspection due to surface finishing defect on august 1, 2016.This finishing issue did not contribute to compliant condition as unrelated to bend parts.No non-conformances or rework were noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 order # (b)(4) was delivered to the facility september 23, 2016 with five (5) devices out of the (b)(4) line shipment being bent.The reporter states that when the shipment was received the receiving guys stated that the outside packaging did not appear to have any damage.There is no case of patient involvement.There are 5 parts in this complaint this report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed.A bent 2.8mm guide wire of part number # 02.207.001 that was contained in an unopened package was received.Investigation determined that the product is bent at approximately a 40 degree angle.The complaint related features of product material and overall diameter meet the specifications.However, the overall length is unobtainable due to bent/damaged product.No manufacturing related issue was identified and/or confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.8MM GUIDE WIRE WITH FLUTES 450MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6037832
• MDR Text Key: 57919072
• Report Number: 3003506883-2016-10171
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• 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,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.207.001
• Device Lot Number: H144780
• Other Device ID Number: (01)10886982051721(10)H144780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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