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

Catalog Number	286735200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
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
Viper mis rod holder broke.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed a fracture at the rod holder¿s distal tip.The remaining distal tip was not returned for evaluation.Device was then sent for fracture analysis.The fracture analysis report notes that the fractured surfaces exhibit rough characteristics that extends across the entire surface suggesting that the tip underwent a static overload failure.No material defects or other abnormalities have been identified in the fracture analysis report.A definitive root cause for the rod holder¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report notes that the fractured surfaces exhibit rough characteristics that extends across the entire surface suggesting that the tip underwent a static overload failure.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.A trend analysis was conducted.No emerging trends were found requiring further actions.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, 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.

• Brand Name: VIPER2 ROD HOLDER, ADVANCED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7121318
• Report Number: 1526439-2017-50086
• Device Sequence Number: 1423563
• Product Code: LXH
• UDI-Device Identifier: 10705034214542
• UDI-Public: 10705034214542
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 11/29/2017

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 Catalogue Number: 286735200
• Device Lot Number: 1108MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR