MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM POLYAXIAL SCREW DRIVER T20; SCREWDRIVER

Model Number	186727750
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mis ti cfx fen poly 7x50 (part # 186727750/ lot # 274579) was received at us cq.Upon visual inspection it was noticed that the broken tip of the viper poly screwdriver was lodged inside the shank of the screw and was unable to be disassembled.The anodization was noticed to be fading.No other issues were identified on the device.The overall complaint was confirmed for the received mis ti cfx fen poly 7x50 (part # 186727750/ lot # 274579).The possible root cause would be that the logged condition of the broken screwdriver tip within the screw shank could have restricted the further advancement of the screw, hence needed to be removed from the patient.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 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: the dhr of product code 186727750, lot 274579, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on march 12, 2020.The dhr was electronically reviewed.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 an unknown procedure, the tip of the screwdriver broke off and was stuck in the head of the screw.The screw had to be changed because it had not been tightened enough.To remove the screw, an expedium rod with an expedium innie with torque was connected to the screw which was then removed with a rotation stabilizer.The screw was removed and a new screw was implanted.There was a surgical delay of five (5) minutes.The surgery was successfully completed.There was no patient consequence.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1), unknown set screws (part# unknown, lot# unknown, quantity 1).This report is for one (1) viper system polyaxial screw driver t20.This is report 2 of 2 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.H10 additional narrative: b4: alert date updated.H4: manufacturing date 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: VIPER SYSTEM POLYAXIAL SCREW DRIVER T20
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10437918
• Report Number: 1526439-2020-01504
• Device Sequence Number: 11375752
• Product Code: HXX
• UDI-Device Identifier: 10705034282688
• UDI-Public: (01)10705034282688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/29/2020

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: 186727750
• Device Catalogue Number: 186727750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.; VIPER UNIVERSAL POLY DRIVER.