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

Model Number	262000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3014334038-2022-00122
• Device Sequence Number: 20083499
• Product Code: HBG
• UDI-Device Identifier: 10381780128410
• UDI-Public: 10381780128410
• Combination Product (Y/N): N
• PMA/510(K) Number: K902818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown