MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI ROD 240MM; APPLIANCE,FIXATION,SPINAL INTERLAMINAL

Model Number	498.957
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 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.
Event or Problem Description
It was reported on (b)(6) 2020 that two (2) titanium rods and one (1) titanium curved rod were broken during a reverse logistics audit of the returned device at millstone.There was no patient involvement and no additional information is available.This report is for one (1) 3.5mm ti rod 240mm.This is report 1 of 3 for (b)(4).
Event or Problem 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.
Additional 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.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 ROD 240MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10164990
• Report Number: 2939274-2020-02886
• Device Sequence Number: 3731978
• Product Code: KWP
• UDI-Device Identifier: 10705034792316
• UDI-Public: 10705034792316
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K994187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498.957
• Device Catalogue Number: 498.957
• Device Lot Number: 5408545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1