MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT RATCHETING HANDLE, CANNULATED; MISC ORTHO SURGICAL INSTR

Model Number	286715300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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: it was reported that on (b)(6) 2019, the screw slipped off pedicle and was inserted into l4/5 disc space.Brainlab jam shiidi and 1.45mm guidewire were also used.The v2 ratcheting t handle was unable to be removed after the procedure.Surgical delay of thirty minutes was reported.This report is for one (1) viper2 straight ratcheting handle, cannulated.This is report 3 of 4 for (b)(4).

• Brand Name: VIPER2 STRAIGHT RATCHETING HANDLE, CANNULATED
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9706249
• Report Number: 1526439-2020-00531
• Device Sequence Number: 2396081
• Product Code: LXH
• UDI-Device Identifier: 10705034214023
• UDI-Public: (01)10705034214023
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 286715300
• Device Catalogue Number: 286715300
• Device Lot Number: GB50741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1