MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME X-TAB, 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186760245
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwp;kwq;mnh;mni;osh.Investigation summary: visual inspection: upon visual inspection there were no issues/damage noted on the implant that would lead to the complaint condition.Functional test: a functional test was not performed as the mating device (viper prime stylet) was not returned.Dimensional inspection: a dimensional inspection could not be performed as the geometry of the screw head it inaccessible without damaging the implant.Document/specification review: viper prime x-tab screw assembly.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: a definitive root cause for this complaint could not be determined as its unconfirmed.During the investigation, no product design, or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective, and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for viper prime x-tab, 6x45mm ti was conducted identifying that lot number tbaddm was released in a single batch.Batch1: lot was released on may 19, 2020 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 history review: 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
It was reported that on (b)(6) 2020, during an unknown procedure, the surgeon was placing the l5 pedicle screw on the patient's right using the viper prime system.When the surgeon confirmed the tip of the screw/driver assembly was properly positioned via intra-operative fluoro, he advanced the prime stylet approximately 3mm in the pedicle and used a mallet to advance the extended stylet until it was fully seated.The surgeon felt that when he deployed the stylet to approximately 15mm, he was unable to continue to advance the stylet due to hard bone.The surgeon confirmed with intro-operative fluoro that the stylet was not advancing, and it became evident from the image that the stylet was bent at the distal end of the screw.The surgeon attempted to remove the screw/driver/stylet assembly from the pedicle.Once removed from the incision, the staff attempted to remove the bent stylet from the screw/driver assembly.While the staff continued to attempt to remove the bent stylet, they assembled a new driver/stylet, and proceeded to load a new 6.0x45mm prime screw.The surgeon inserted the new screw with new driver assembly with no further issues.After the procedure was completed, they attempted to remove the bent stylet from the screw.Unfortunately, the stylet broke inside of the screw implant where it had been bent excessively in an effort to remove on the back table.They were able to contain the parts of the driver, screw, and stylet from the field, and requested decontamination of the items for return.They were not able to remove the broken piece of the stylet from the inner cannula of the implant itself.There was a surgical delay of ten (10) minutes.Fragments were generated and removed easily.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown mallet (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper prime x-tab, 6x45mm ti.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER PRIME X-TAB, 6X45MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10809285
• Report Number: 1526439-2020-02127
• Device Sequence Number: 3500682
• Product Code: NKB
• UDI-Device Identifier: 10705034509266
• UDI-Public: (01)10705034509266
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 186760245
• Device Catalogue Number: 186760245
• Device Lot Number: TBADDM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN EXTRACTION INSTRUMENTS; VIPER PRIME INSERTER SHAFT; VIPER PRIME STYLET