MAUDE Adverse Event Report: DEPUY SPINE INC HEXLOBE DRIVER, POLY SCREW X15; DRIVER, PROSTHESIS

Model Number	277020030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
It was reported that the patient was operated on today (b)(6) 2019 by surgeon at the (b)(6).This case was booked with prism surgical and when the prism representative was there they discovered that it was a revision of a previous construct which had used monarch pedicle screws.The prism representative called to inform me that two of the monarch screw drivers 2770-20-303 were damaged during the removal of the pedicle screws, one broke and one driver stripped.No further information was given apart from that all implants were successfully removed.The prism representative is unsure if the drivers are available for return.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HEXLOBE DRIVER, POLY SCREW X15
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8611995
• Report Number: 1526439-2019-51640
• Device Sequence Number: 2022174
• Product Code: HWR
• UDI-Device Identifier: 10705034196435
• UDI-Public: (01)10705034196435
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/23/2019

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: 277020030
• Device Catalogue Number: 277020030
• Device Lot Number: G0104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/10/2019; 08/14/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/15/2019; 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1