MAUDE Adverse Event Report: DEPUY SPINE INC UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	289707000
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact date of event is unknown; event occurred sometime in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.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 (b)(6) reports an event as follows: it was reported the patient underwent anterior spine surgery with a skyline plate.After tightening the camlock of the plate, the camlock had to be reopened.As the left turn was executed with the torque limiting handle and camlock screwdriver, the handle gave way and later unscrewed itself and fell apart.The unlocking of the screws had to be performed with the camlock screwdriver shaft and a jacobs chuck.This report is for a torque limiting handle.This is report 1 of 1 for (b)(4).

• Brand Name: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12527163
• Report Number: 1526439-2021-02066
• Device Sequence Number: 4232047
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 08/26/2021
• Initial Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SKY CAM TIGHTENER SHAFT; UNKNOWN PLATES; UNKNOWN SCREWS