MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 T20 HEXLOBE DRIVER SHAF; DRIVER, PROSTHESIS

Model Number	286725020
Medical Device Problem Codes	Material Twisted/Bent (2981); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for viper2 t20 hexlobe driver shaf was conducted identifying that lot number x0910 was released in a single batch.Batch1: released on (b)(6) 2011 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: the viper t20 hexlobe driver shaft was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the distal tip of the device was twisted and broken, but the broken fragment was not returned.No other issues were observed with the returned device.Dimensional inspection: the distal tip was measured to be within the specification per drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Viper2 t20 hexlobe driver.Investigation conclusion: the complaint condition was confirmed for the viper t20 hexlobe driver shaft.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 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 (b)(6) reports an event as follows: it was reported that a patient was treated with a viper cfx screw for stabilization.During the placement of a cfx-screw with unknown diameter, the t20 tip of the viper sc driver was stripped.Before placing further screws, the surgeon wanted to use the thread cutter to prepare the thread.While removing the thread cutter, the tip of the instrument broke off on the smooth golden part.The broken off part could not be removed from the patient.To complete the surgery, a viper 2 t20 screwdriver shaft was used.Procedure was completed with a delay of thirty to sixty (30 ¿ 60) minutes.Patient outcome was good.This report is for a viper2 t20 hexlobe driver shaft.This is report 3 of 3 for (b)(4).
Event or Problem Description
Additional event description.The procedure was completed successfully.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: b5: additional event information updated.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: investigation summary: investigation flow: damage.Visual inspection: the viper t20 hexalobe driver shaft (p/n: 286725020, lot #: x0910) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was twisted and broken, but the broken fragment was not returned.No other issues were observed with the returned device.The device failure/defect was identified.The complaint was confirmed.The device received was broken.Hence confirming the allegation.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Investigation conclusion : the complaint condition was confirmed for the viper t20 hexalobe driver shaft (p/n: 286725020, lot #: x0910).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 viper2 t20 hexalobe driver shaf was conducted identifying that lot number x0910 was released in a single batch.Batch1: lot qty of (b)(4) units were released on feb 16, 2011 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.

• Brand Name: VIPER2 T20 HEXLOBE DRIVER SHAF
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11710609
• Report Number: 1526439-2021-00773
• Device Sequence Number: 3946510
• Product Code: HWR
• UDI-Device Identifier: 10705034214290
• UDI-Public: (01)10705034214290
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 286725020
• Device Catalogue Number: 286725020
• Device Lot Number: X0910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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 SCREWS; VIPER UNIVERSAL POLY DRIVER; VIPER2 5MM SELF DRILLING TAP,