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 nw141998 was released in two batches.Batch1: released on august 13, 2014 with no discrepancies.Batch2: released on august 14, 2014 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 device approximator fc sleeve was returned to customer quality (cq) west chester for investigation.During visual inspection, a foreign object was found lodged inside the sleeve.The tip of the sleeve had been nicked.Functional test: a functional test could not be performed as the sleeve was not returned with a mating device.Also, this would not have been possible as the hollow portion of the sleeve was blocked.Dimensional inspection: this is deemed irrelevant as the complaint condition was due to the presence of an unknown object in the hollow 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 sleeve had been blocked by a foreign object which might have rendered the sleeve non-functional.A definitive assignable root cause of this issue 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: 12953084
• MDR Text Key: 281858119
• Report Number: 1526439-2021-02508
• 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: NW141998
• 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: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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