MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER CARRIER SURGICAL SCREWDRIVER, REUSABLE

Model Number 286750033

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

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. Additional narrative: a device history review was performed, and no non-conformances were detected related to the reported condition. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j sales representative. 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, during a posterior lumbar interbody fusion (plif) for treating spinal canal stenosis the inserter handle was attached to the inserter carrier and a red powder-like foreign substance came out. They reattached the devices a few times, but the foreign substance came out over and over. The devices were not used in the procedure, and the procedure was completed without surgical delay. This report is for one (1) viper prime inserter carrier. This is report 2 of 2 for complaint (b)(4).

• Brand Name: VIPER PRIME INSERTER CARRIER
• Type of Device: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14222794
• MDR Text Key: 294270397
• Report Number: 1526439-2022-00624
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 286750033
• Device Catalogue Number: 286750033
• Device Lot Number: MF4407603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown