MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CUSHING RONG 7 2X10MM STR; N/A

Model Number 280405

Device Problem Difficult to Open or Close (2921)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that during surgery, the cushing ronguer 7 2x10mm str (280405) was not biting/closing properly; the upper and lower jaw were not touching or cutting properly.No patient injury occurred; however, there was an estimated 30-minute increase in surgery time.

Manufacturer Narrative

The cushing ronguer 7 2x10mm str (280405) was subsequently returned to the manufacturer for evaluation: failure analysis: visual and functional evaluation of the cushing ronguer found that the device had its lower jaw cracked and bent out of alignment, preventing the jaws from meeting.The lower jaw was fixed in place.Root cause: the reported complaint was confirmed.The crack and displacement indicated excessive force due to rough handling or environmental damage.No manufacturing, workmanship or material deficiency has been identified.

Manufacturer Narrative

The cushing ronguer 7 2x10mm str (280405) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.Visual evaluation of video provided by the customer showed that the ronguer had its lower jaw hanging loosely, preventing the jaws from meeting.This issue may be the result of a damaged or missing set screw on the lower jaw due to wear or rough handling.No manufacturing, workmanship or material deficiency has been identified.The reported complaint was confirmed.No further investigation sis required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: CUSHING RONG 7 2X10MM STR
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16883840
• MDR Text Key: 314717680
• Report Number: 3014334038-2023-00059
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10381780385783
• UDI-Public: 10381780385783
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 280405
• Device Catalogue Number: 280405
• Device Lot Number: AB2207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/07/2023
• Supplement Dates Manufacturer Received: 05/31/2023; 08/07/2023
• Supplement Dates FDA Received: 06/13/2023; 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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