MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM EXT. TAB BREAKER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286760210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during a posterior thoracolumbar fusion in th11-l4 treating a rupture fracture, when the surgeon tried to break off a new screw's tabs with the tab breaker, possibly fragmented tab(s) came out of the tab breaker.The fragmented tab(s) was not the one the surgeon tried to break off.The procedure was completed without surgical delay.Concomitant devices: unknown screws (part# unknown, lot# unknown, quantity unknown); unknown setscrews (part# unknown, lot# unknown, quantity unknown); unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper 2 system ext.Tab breaker.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: VIPER 2 SYSTEM EXT. TAB BREAKER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10431259
• Report Number: 1526439-2020-01493
• Device Sequence Number: 2392382
• Product Code: LXH
• UDI-Device Identifier: 10705034214924
• UDI-Public: 10705034214924
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 286760210
• Device Catalogue Number: 286760210
• Device Lot Number: PC2153875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS