MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CURVED ROD 40MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number 498.136

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional device product codes: (b)(4).The device has been 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 the three (3) 6.0mm titanium soft rod 500mm, five (5) 3.5mm titanium rod 240mm, one (1) 3.5mm titanium curved rod 80mm, and one (1) 3.5mm titanium curved rod 40mm were found broken during reverse logistics audit of returned devices.There was no patient involvement and no additional information is available.This report is for one (1) 3.5mm ti curved rod 40mm.This is report 10 of 10 for complaint (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.Originally the devices were reported as broken.Further information was received indicating the devices were remnants of implants that were purposefully cut during the surgery.There was no malfunction of the device.

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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.Originally the devices were reported as broken.Further information was received indicating the devices were remnants of implants that were purposefully cut during the surgery.There was no malfunction of the device.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: 3.5MM TI CURVED ROD 40MM
• Type of Device: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10160026
• MDR Text Key: 195404575
• Report Number: 2939274-2020-02829
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034788975
• UDI-Public: (01)10705034788975
• Combination Product (y/n): N
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 498.136
• Device Catalogue Number: 498.136
• Device Lot Number: 3271723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 06/25/2020
• Patient Sequence Number: 1