MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME X-TAB, 7X45MM TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186770245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional pro-codes: mnh, kwp, osh, kwq, mni.A review of the receiving inspection (ri) for viper prime x-tab, 7x45mm ti was conducted identifying that lot number tbslw was released in a single batch.Batch1: lot qty of (b)(4) units were released on 11 sep 2017 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 batch null, 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.Investigation summary: background: libertas: it was reported that on (b)(6) 2021, the viper prime x-tab, 7x45mm ti was broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves 1 number of device.Investigation flow: damage.Visual inspection: viper prime x-tab, 7x45mm ti (part: 186770245, lot: tbslw, qty: 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the most distal tip of the screw shank got broken.No other damage was noticed with the returned device.Thus, the complaint is being confirmed.Device failure/ defect was found.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to post manufacturing damage.Documentation/ specification review: the following drawing(s) was reviewed: no design issues or discrepancies were found during this investigation.Complaint was confirmed.Investigation conclusion: the complaint is being confirmed for viper prime x-tab, 7x45mm ti (part: 186770245, lot: tbslw) as the most distal tip of the screw shank got broken.While a definitive root cause could not be determined for the reported problem, it is possible that the tip of the device got encountered unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 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) 2021, the viper prime x-tab, 7x45mm ti was broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.Concomitant product: viper prime x-tab, 7x45mm ti.This complaint involves one (1) viper prime x-tab, 7x45mm ti.This report is1 of 1 for (b)(4).

• Brand Name: VIPER PRIME X-TAB, 7X45MM TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11379098
• Report Number: 1526439-2021-00358
• Device Sequence Number: 3785978
• Product Code: NKB
• UDI-Device Identifier: 10705034509471
• UDI-Public: (01)10705034509471
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 186770245
• Device Catalogue Number: 186770245
• Device Lot Number: TBSLW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1