MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 SCREW EXTENSION, OPEN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286725300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
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.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported that during a spinal fusion procedure on (b)(6) 2020, the nurse was trying to attach the screw extension and this screw extension would not attach to the screw.The nurse placed it aside and took another screw extension for the case.Therefore there was no delay in the case and the patient was not impacted.This report is for one (1) viper2 screw extension, open.This is report 1 of 1 for complaint (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: d4: lot number, expiration date h3, h6: a product investigation was conducted.Visual inspection: the viper2 screw extension, open (p/n: 286725300, lot number: mi26724) was received at us cq.Visual inspection of the complaint device showed no damage to the device.Functional test: a functional assessment was unable to be performed on the complaint device due to no mating devices returned.The complaint was not able to be replicated.Dimensional inspection: no dimensional inspection was performed as it would not pertain to the complaint condition.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as a the mating devices were not returned and there is no damage.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: product code: 286725300, lot number: mi26724, release to warehouse date: 07feb2013.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition 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, OPEN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10886817
• Report Number: 1526439-2020-02267
• Device Sequence Number: 16867671
• Product Code: LXH
• UDI-Device Identifier: 10705034214351
• UDI-Public: (01)10705034214351
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 286725300
• Device Catalogue Number: 286725300
• Device Lot Number: MI26724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1