MAUDE Adverse Event Report: DEPUY SPINE INC APPROXIMATOR FC SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 279712580

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.A review of the receiving inspection (ri) for approximator fc sleeve was conducted identifying that lot number nw166401 was released in a single batch.Batch1: released on september 20, 2016 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 complaint devices approximator fc sleeve was returned to customer quality (cq) west chester for investigation.During visual inspection, an expedium single innie was found inside the sleeve.Also, the device tip had been nicked and the lot number & part number marking were faded.Functional test: a functional test of could not be performed as the device was returned without a mating device.Also, the sleeve was blocked by another item due to which a functional evaluation would not have been possible.Dimensional inspection: a dimensional inspection was not performed as the reason for the non-functioning of the device was identified to be a blockage of the sleeve.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Conclusion: the complaint condition can be confirmed during physical device investigation.The expedium 5.5 reduction sleeve was blocked by a single innie and had damaged tip.A definitive assignable root cause could not be determined from the available 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.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

It was reported that during routine incoming inspection of a loaner set on an unknown date, it was observed that the approximator fc sleeve was non-functional.There is no known patient or hospital involvement.This report is for a approximator fc sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: APPROXIMATOR FC SLEEVE
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12955474
• MDR Text Key: 286445819
• Report Number: 1526439-2021-02511
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034199009
• UDI-Public: (01)10705034199009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712580
• Device Catalogue Number: 279712580
• Device Lot Number: NW166401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1