MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM GUIDE WIRE 350MM; PIN, FIXATION, THREADED

Model Number 357.039

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional procode: jds.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

It was reported that on an unknown date, the guide wire was bent during shipping.There was no patient involvement.This report is for a 2.8mm guide wire 350mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: part number: 357.039.Lot number: h821520.Part manufacturing date: 08 february 2019.Manufacturing site: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h821520 of guide wires was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h615761 met all specifications with no issues documented that would contribute to this complaint condition.A product investigation was conducted.Visual inspection: 2.8mm guide wire 350mm was received at cq with undamaged package.Upon visual inspection at cq, it is observed that the guide wire is bent.Thus, the reported complaint is confirmed.Dimensional inspection: dimensional inspection was performed on the returned device.The outer diameter of the guide wire was intended to measuring from 2.7mm to 2.8mm and was measured to be 2.78mm which is within specifications.The received condition was determined to agree with the complaint description.The complaint is confirmed.Document/ specification review: the relevant drawing(s) was reviewed; no design issues or discrepancies were found during this investigation.Investigation conclusion: a visual inspection, dimensional inspection, and document/ specification review were performed and observed that the guide wire was bent in undamaged package.Thus, the reported complaint is confirmed.It is possible that the device might have encountered unintended forces during storage or transportation.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based upon these results, no corrective and/or preventative action is proposed.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: 2.8MM GUIDE WIRE 350MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8711764
• MDR Text Key: 148415964
• Report Number: 2939274-2019-58736
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 10886982195692
• UDI-Public: (01)10886982195692
• Combination Product (y/n): N
• PMA/PMN Number: K970097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357.039
• Device Catalogue Number: 357.039
• Device Lot Number: H821520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1