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	06/07/2022
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, it was hot and the metallic part got stuck in the bone.The procedure was completed with a replacement product available.No patient injury, no surgical delay.Test was done before use and it was working as expected.The motor used is motor hose aesculap b braun and the speed was 60000 turn / minutes.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The perforator was returned for evaluation: 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.The perforator unit returned was noted to have a deformed sleeve, likely due to heat, and was separated where the outer drill and white flange meet.The unit was returned without the spring.Ifu testing was performed with no observed anomalies once re-sleeved because it could not be tested in the as-received condition.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended.The complaint could not be verified through failure analysis.Root cause - the complaint was unable to be confirmed in the complaint evaluation.A review of the device history record and trending were performed as part of the evaluation.Likely root cause includes user misuse.

• 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: 14843331
• Report Number: 3014334038-2022-00134
• Device Sequence Number: 17329555
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: J8941P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/20/2022
• 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