MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN 9MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Model Number	261223
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A facility reported a perforator (id 261223) did not disengage during making the first hole.When attempted to retrieve it from patient's head, it broke in two parts.The procedure was completed with a replacement product available.No patient injury and no surgical delay reported.
Additional Manufacturer Narrative
Dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Visual inspection utilizing unaided eye found that the unit was received disassembled and had a cracked sleeve along the based of the flanged nyliner.Upon inspection, the base of the flanged nyliner was compressed and had an od that was wider than the top of the hudson end, causing it to protrude and cut into the sleeve.Ifu testing was performed after the unit was re-assembled.It was re-assembled using the original nyliner, but the unit would not rotate freely.When re-assembled with a new nyliner, it functioned as intended.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to not perform as intended with the original flanged nyliner, the original nyliner in the manufactured product is what cause the unit to break apart.In the failure analysis that was performed, the returned unit did not work as intended, and the complaint condition of breaking was confirmed.The complaint could be verified through failure analysis.Root cause - the failure analyst noted in their investigation that the flanged nyliner is the root cause of the perforator breaking.However, the root cause of failure to disengage is unconfirmed and it is not possible to know what cause the failure to disengage.The nyliner causing the breakage would not have caused the unit to fail to disengage, per the analyst, it would have made it easier to stop the unit due to the resistance it was causing.The possible root cause for the failure to disengage would be user misuse, since other manufacturing defects were eliminated.

• Brand Name: CODMAN 9MM DISPOSBL PERFORATR
• Common Device Name: DISPOSABLE PERFORATORS
• 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: 13862194
• Report Number: 3014334038-2022-00059
• Device Sequence Number: 5371417
• Product Code: HBF
• UDI-Device Identifier: 10381780513612
• UDI-Public: 10381780513612
• Combination Product (Y/N): N
• PMA/510(K) Number: K071931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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 Expiration Date: 07/31/2025
• Device Model Number: 261223
• Device Catalogue Number: 261223
• Device Lot Number: J8940R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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