MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 ROD HOLDER, ANGLED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286735100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Viper2 rod holder, angled was received by the customer quality unit for evaluation.Visual examination at the macroscopic level found that the distal tip of the rod holder had fractured.The other half of the tip was not returned for evaluation.A fracture analysis was performed.The fracture analysis exhibits two surface morphologies, a smooth region and a grainy/rough region which are indicative of fatigue failure.A device history record review did not identify any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the viper2 rod holder, angled fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies, a smooth region and a grainy/rough region which are indicative of fatigue failure.As no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, this complaint file will be closed with no further action required.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 surgeon had a very difficult case with a patient who had very hard bone.The surgeon chose not to tap the bone prior to screw insertion which resulted in higher than normal bone/screw insertion torque.This resulted in screw driver tip breakage.Secondarily, the surgeon was trying to pass a rod with a severe bend up the spine from the pelvis up to t10.After putting a very lordotic bend into the rod while attached to the rod holder, he then put a lot of force on the rod/rod holder interface while passing up the spine.Patient consequence? : no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: VIPER2 ROD HOLDER, ANGLED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8089304
• Report Number: 1526439-2018-51084
• Device Sequence Number: 16508814
• Product Code: LXH
• UDI-Device Identifier: 10705034214504
• UDI-Public: (01)10705034214504
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: 286735100
• Device Catalogue Number: 286735100
• Device Lot Number: 1108MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1