MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 SCREW EXTENSION, CLOSED; MISC ORTHO SURGICAL INSTR

Model Number	286725200
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, during pre-op for a procedure, the extensions had been cracked.The tip of the poly driver shaft was broken and unable to engage into the screw.Also, the threaded post of the x25 driver is not staying and continues to slide off.There were no patient consequences.The procedure outcome is unknown.Concomitant device reported.Unknown screws (part# unknown, lot# unknown, qty unknown).This complaint involves five (5) devices.This report is for (1) viper2 screw extension, closed.This report is 1 of 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: a review of the receiving inspection (ri) for viper2 screw extension, closed was conducted identifying that lot number 0310mi was released in three batches.Batch1: lot qty of (b)(4) units were released on may 28, 2010 with no discrepancies.Batch2: lot qty of (b)(4) units were released on september 15, 2010 with no discrepancies.Batch3: lot qty of (b)(4) units were released on september 16, 2010 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 viper2 screw extension, closed (part #: 286725200, lot #: 0310mi) was received at us customer quality (cq).Visual inspection of the complaint device showed that the outer sleeve was cracked.Surface scratches were also observed on the outer sleeve.Functional test: a functional assessment was not performed with the complaint device due to the post manufacturing damage.Can the complaint be replicated with the returned device? unable to perform.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits ability to accurately dimensionally inspect document/specification review: viper2, closed extension current and manufactured revisions were reviewed outer sleeve, viper2 closed extension - current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed during the investigation as the complaint device was found to be cracked.The crack condition could impact the functionality of the device with mating devices.However the reporter condition as stripped/torn/twisted could not be confirm.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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.

• Brand Name: VIPER2 SCREW EXTENSION, CLOSED
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12470911
• Report Number: 1526439-2021-02012
• Device Sequence Number: 3779569
• Product Code: LXH
• UDI-Device Identifier: 10705034214313
• UDI-Public: (01)10705034214313
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 286725200
• Device Catalogue Number: 286725200
• Device Lot Number: 0310MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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: POLYAXIAL SCREW DRIVER SHAFT; REDUCTION THREADED POST; UNKNOWN SCREWS; VIPER2 FINAL TIGHTENER DRIVER; VIPER2 SCREW EXTENSION, CLOSED; POLYAXIAL SCREW DRIVER SHAFT; REDUCTION THREADED POST; UNKNOWN SCREWS; VIPER2 FINAL TIGHTENER DRIVER; VIPER2 SCREW EXTENSION, CLOSED