MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD480MM, COCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196789480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event occurred on an unknown day in (b)(6) of 2020.Additional procode: kwp; kwq; mnh; mni; osh.Occupation: reporter is a j&j employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 in (b)(6) of 2020, the viper2 straight rod was broken under the use of the insitu bender from the expedium 5.5 system.The procedure outcome is unknown.There was no patient consequence reported.Concomitant device reported: unknown bender (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper2 straight rod480mm, cocr.This is report 1 of 1 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.H10 additional narrative: h6: a review of the receiving inspection (ri) for viper2 straight rod480mm, cocr was conducted identifying that lot number gm54821 was released in a single batch.Batch 1: released on july 26, 2019 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.Visual inspection; viper2 straight rod480mm, cocr was returned and received at us customer quality (cq).The rod was received bent and broken.Per the complaint description, which describes an issue occurring 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 measured: three distinct locations along shaft result: conforming document/specification review the following drawings were reviewed: viper- straight rod, cobalt chromium.No design issues or discrepancies were identified during investigation.Investigation conclusion: the received condition of the device viper2 straight rod480mm, cocr was found to be broken.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 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
Procedure was completed with a ten (10) minute delay.The surgeon had to organize another root.The surgeon commented that: the root was bent 2-3 times at different places to attend the right kyphosis.The approximate angle during the bending (until the break) was not more then 10 degrees.
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.H10 additional narrative: e1: initial reporter information updated.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: VIPER2 STRAIGHT ROD480MM, COCR
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10526263
• Report Number: 1526439-2020-01647
• Device Sequence Number: 14064713
• Product Code: NKB
• UDI-Device Identifier: 10705034295275
• UDI-Public: (01)10705034295275
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup,Followup
• Report Date (Section B): 08/16/2020

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: GM54821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/16/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 10/16/2020
• Initial Report FDA Received Date: 09/13/2020
• Supplement Report FDA Received Date: 10/14/2020; 10/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BENDING INSTRUMENTS