MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VERTEBRAL BODY RETAINER; MISC ORTHO SURGICAL INSTR

Model Number	03.820.112
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date a vertebral distractor prodisc c spring is falling out of 1 out of the 2 arms of the device.The cause of the spring issue is unknown as the instrument was believed to be part of acceptable centinel stock.The distributing partner identified the issue upon receipt of the instrument set.There was no surgical procedure involved, scheduled, or affected by the problem.There was no patient involvement.This complaint involves one (1) vertebral distractor prodisc c.This is report 1 of 1 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the complaint device was not received for investigation.The following investigation is based on the image provided in attachment ¿(b)(4) intake email with image of the device from centinel spine (b)(6) 2019¿.Customer quality investigation: one photo of the vertebral body retainer (p/n 03.820.111, lot t140161) was received showing the left and right torsion spring protruding out of their respective compression ratchets.It can be visually confirmed that the springs have shifted out from their original positions.As the vertebral body retainer was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the provided photos.No definitive root cause was able to be determined.During the investigation no product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history lot.Part number: 03.820.111, lot number: t140161, manufacturing site: (b)(4).Release to warehouse date: feb 03, 2019.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.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: VERTEBRAL BODY RETAINER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9178893
• Report Number: 2939274-2019-61279
• Device Sequence Number: 16846925
• Product Code: LXH
• UDI-Device Identifier: 10705034731537
• UDI-Public: (01)10705034731537
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 09/18/2019

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: 03.820.112
• Device Catalogue Number: 03.820.111
• Device Lot Number: T140161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1