MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.026

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records has been requested.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 orthopedic restock station noticed the helical blade/screw coupling screw is stripped.The device will not correctly align with the helical blade/screw inserted.It is not known when or how this issue occurred.There was no patient involvement.This report is for one (1) helical blade/screw coupling screw.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.Additional narrative: device history records review was completed for part: 03.037.026, lot: 9569646.Manufacturing location: bettlach, release to warehouse date: jul 16, 2015.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.The helical blade/ screw coupling screw was received with minimal signs of wear of the overall device.The distal threads are in a good condition.The proximal threads are stripped and look slightly deformed.This is consistent with the reported complaint condition, thus confirming the complaint.A functional test could not be performed since the helical blade/coupling screw was returned by itself.The complaint for the product not correctly aligning with the helical balde/screw could not be replicated and therefore could not be confirmed.However, the complaint is confirmed for the stripped screw.Dimensional analysis was completed, the threaded diameter of the distal shaft, measured 5.89 mm.This is within specification of 5.82 mm to 6.00 mm, based on drawing.The threaded diameter of the proximal shaft, measured 8.80 mm.This is within specification of 8.794 mm - 8.974 mm (m9), based on drawing and thread tolerance specification.The relevant drawings were reviewed.The complaint condition is confirmed as the helical blade/ screw coupling screw was received with the proximal threads stripped.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off axis or damaged during sterile processing).No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that 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: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8198090
• MDR Text Key: 131496232
• Report Number: 2939274-2018-55591
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)10886982070425
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.026
• Device Catalogue Number: 03.037.026
• Device Lot Number: 9569646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/18/2019
• Patient Sequence Number: 1