MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD INGE SPREADER 6; M6 - NEURO

Model Number 262000

Device Problem Mechanical Problem (1384)

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

Event Date 05/15/2022

Event Type  malfunction  

Event Description

A facility reported that the doctor used the inge spreader (26-2000) for the first time and the tension released on its own during an unspecified procedure.No patient injury or death occurred; no surgical delay was reported.

Manufacturer Narrative

The inge spreader (26-2000) was returned for evaluation.Device history record review: no abnormalities related to the reported issue were identified.Failure analysis: evaluation of the returned 26-2000 inge spreader found that the handle was stiff and difficult to lock due to a damaged set screw.Debris from the screw damage was visible between the hinges.Root cause analysis: the returned 26-2000 inge spreader was in used condition with damage to the set screw due to environmental damage.Damaged set screw made the handles stiff and difficult to lock.The reported complaint was confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: INGE SPREADER 6
• Type of Device: M6 - NEURO
• 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: 14759949
• MDR Text Key: 303086496
• Report Number: 3014334038-2022-00122
• Device Sequence Number: 1
• Product Code: HBG
• UDI-Device Identifier: 10381780128410
• UDI-Public: 10381780128410
• Combination Product (y/n): N
• PMA/PMN Number: K902818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 262000
• Device Catalogue Number: 26-2000
• Device Lot Number: AM2003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• 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