MAUDE Adverse Event Report: DEPUY SPINE INC CAP INSERTER; DRIVER, PROSTHESIS

Model Number	277040700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Removal of the monarch system was reported: dr (b)(6), (b)(6) hospital (b)(6) 2018.Primary implant date 2011.Revision: removing implants for scoliosis correction.Both instruments broke at the distal tips on trying to remove the typhoon set cap - this was due to bone formation around the screw head.No adverse affect to the patient and no time wasted as we could use other ones on the set and removed the bone prior to the third and forth attempt.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: CAP INSERTER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7776709
• Report Number: 1526439-2018-50778
• Device Sequence Number: 11153271
• Product Code: HWR
• UDI-Device Identifier: 10705034196879
• UDI-Public: (01)10705034196879
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: 277040700
• Device Catalogue Number: 277040700
• Device Lot Number: T0508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1