MAUDE Adverse Event Report: DEPUY SPINE INC UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM; CAM TIGHETENER TORQUE HANDLE

Model Number	289707000
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes rep.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: the procedure was an acdf, and uniplate was used.The torque handle is damaged and caused the torque to snap while carrying out the final tightening.The procedure was delayed by 5-10 minutes as we had to source another kit and use the handle and shaft from there.Didn¿t affect the patient outcomes though and the patient wasn¿t harmed in the process.This was also not a clinical trial.The surgeon went to final tighten the cam loc on the plate and he torque handle normally clicks to let him know he¿s turned it enough - this failed to happen causing the shaft to snap into the lock.Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: 1).This complaint involves two (2) devices.This report is for one (1) uniplate anterior cervical plate system.This report is 1 of 2 for (b)(4).

• Brand Name: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: CAM TIGHETENER TORQUE HANDLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9873317
• Report Number: 1526439-2020-00753
• Device Sequence Number: 14172655
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 289707000
• Device Catalogue Number: 289707000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1