MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT ROD480MM, COCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	196789480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device deemed reportable during investigation.Investigation summary: visual inspection: the two rods were received bent and broken.Per the complaint description, which describes an issue occurred during contouring and bending of the rods, as well as the intended ability of the rods to be bent to allow for contouring to individual patient anatomy, the bent condition was not considered a malfunction.The fracture surface did not indicate any material abnormalities or issues.Dimensional inspection.Feature: outer diameter of main shaft.Specification: 5.5mm +0/-0.05.Measured: three distinct locations along shaft: 5.475-5.477mm.Result: conforming.Document/specification review: no design issues were identified during investigation.Conclusion: the received condition of the device was found to be broken.The complaint was considered confirmed during investigation as the complaint condition of the device was for a nonspecific functional issue, which a broken device would contribute to.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined as the event details were not provided, but factors that may have contributed to the failure include the rate of bending, angle of the bend, and abnormal forces applied to create the bend.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history: a review of the receiving inspection (ri) for viper2 straight rod480mm, cocr was conducted identifying that lot number gm46547 was released in a two (2) batches.Batch1: lot qty of 29 units were released on (b)(6) 2016 with no discrepancies.Batch2: lot qty of 225 units were released on (b)(6) 2016 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 during a surgery on (b)(6) 2020 the surgeon was bending the rod about 10 cm into the edge of the rod.The rod broke during bending.A second rod broke in the same manner.A surgical delay of 20 minutes was reported.Patient status was reported as good.Concomitant device reported: sagittal in-situ bender, left (part # 299704195, lot # unknown, quantity # 1).Sagittal in-situ bender, right,(part # 299704200, lot # unknown, quantity # 1).French rod bender (part # 299704170, lot # unknown, quantity # 1).This is report 1 of 2 for (b)(4).

• Brand Name: VIPER2 STRAIGHT ROD480MM, COCR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10381322
• Report Number: 1526439-2020-01447
• Device Sequence Number: 19264943
• Product Code: NKB
• UDI-Device Identifier: 10705034295275
• UDI-Public: (01)10705034295275
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K111136
• 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
• Report Date (Section B): 06/11/2020

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: 196789480
• Device Catalogue Number: 196789480
• Device Lot Number: GM46547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/07/2020
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 40