MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN 11MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Model Number	261222
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the label of a perforator (id 261222) came off during use and thus fall in the wound.No patient injury.The procedure was delayed cause they had to search for the pieces of paper in the body of patient but there is no information about exact time.
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 - a visual inspection utilizing the unaided eye performed.Unit had light soiling and a partially worn label but showed no other observable anomalies.Spring test attempted: unit felt slightly "sticky" when rotating the hudson end but was freed by drilling 5 test holes.Once freed, the unit passed the spring test and functioned as designed.Functional test performed: unit had slight difficulty rotating "as received" but the unit was freed by drilling 5 test holes.Once freed the unit functioned as designed and successfully drilled 5 holes with no issues.Because the unit was returned with a worn/damaged eto label the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the analyst could confirm the complaint condition.

• Brand Name: CODMAN 11MM 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: 16635722
• Report Number: 3014334038-2023-00038
• Device Sequence Number: 17966711
• Product Code: HBF
• UDI-Device Identifier: 10381780513605
• UDI-Public: 10381780513605
• 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): 05/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 261222
• Device Catalogue Number: 261222
• Device Lot Number: 6899455
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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