MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH IPER 2 SYSTEM ROD, PRE-LORDOSED 90MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186788090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: nkb, osh, mnh, kwp, and mni.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the receiving inspection (ri) for viper2 lord.Trial rod-90mm was conducted identifying that lot number tbtyw was released in a single batch.Batch1: lot qty of (b)(4) units were released on may 11, 2018 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.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as the image provided shows the broken rod.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a l4-5-s1 posterior stabilization/fusion, a minimally invasive procedure, the small connecting piece on the viper2 rod broke.The small connecting piece broke due to the pressure being placed on the device.The broken fragment was held in the rod.The rod and the fractured piece were easily removed.Another rod was used to complete the procedure.There was a surgical delay of two (2) minutes.The procedure was completed successfully.There were no consequences to the patient.Concomitant device reported: rod holder (part number unknown, lot unknown, quantity unknown).This report involves one (1) viper 2 system rod, pre-lordosed 90mm.This is report 1 of 1 for (b)(4).

• Brand Name: IPER 2 SYSTEM ROD, PRE-LORDOSED 90MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10545920
• Report Number: 1526439-2020-01716
• Device Sequence Number: 3216281
• Product Code: KWQ
• UDI-Device Identifier: 10705034131832
• UDI-Public: (01)10705034131832
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/20/2020

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: 186788090
• Device Catalogue Number: 186788090
• Device Lot Number: TBTYW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS
• Patient Age: 42 YR