MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 SCREW EXT, MULTI PIECE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286725225
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during a procedure on (b)(6) 2021, during insertion, the sleeve loosened several times from the viper screw and was replaced by another sleeve.Procedure was completed successfully with no delay.There was no patient harm.This report is for a viper 2 system multi-piece screw extension closed.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a review of the receiving inspection (ri) for viper2 screw ext, multi piece was conducted identifying that lot number mi30982 was released in a single batch.Batch1: lot qty of (b)(4) units were released on october 10, 2013 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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image.The image was reviewed, and the complaint condition is not confirmed.There are no visible defects or damage with the screw extension in the photo provided.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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.
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.Investigation summary: visual inspection: the viper2 screw ext, multi piece (part# 286725225, lot# mi30982) was returned and received at us cq.Upon visual inspection at cq, it is observed that there was no physical damage to the device.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Functional testing: a complete functional testing of the received device was not performed at cq as the device was received by itself.Can the complaint be replicated with the returned device(s)? unable to perform.Dimensional inspection: dimensional inspection of the received device was not performed at cq as the relevant internal features of the device were inaccessible.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for the received device.A definitive root cause could not be identified for the reported problem.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 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.

• Brand Name: VIPER2 SCREW EXT, MULTI PIECE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12751099
• Report Number: 1526439-2021-02316
• Device Sequence Number: 11126394
• Product Code: LXH
• UDI-Device Identifier: 10705034214320
• UDI-Public: (01)10705034214320
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2021

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: 286725225
• Device Catalogue Number: 286725225
• Device Lot Number: MI30982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/09/2021; 12/17/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/10/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS : VIPER 2 SCREW EXTENSION.; UNKNOWN GUIDES/SLEEVES/AIMING.; UNK - SCREWS : VIPER 2 SCREW EXTENSION; UNKNOWN GUIDES/SLEEVES/AIMING
• Patient Sex: Unknown