MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRILE FCPS 6-1/4 CVD MATTE; N/A

Model Number	107141
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
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 that the pin of the kelly clamp/crile fcps 6-1/4 cvd matte (107141) had come out and fell into a patient while in an open abdominal surgery.The surgeon was able to retrieve the pin, there was a delay of 15 minutes by locating the pin which was eventually irrigated and suctioned into the suction canister.It was reported that there was no patient injury and the patient remained stable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The crile forceps 6-1/4 cvd matte (107141) was not returned to the manufacturer; therefore, an evaluation of the actual device could not be performed.Lot number information has been provided; device history records (dhr) was reviewed, and no anomalies were found.Visual evaluation of photo provided by the customer showed the crile forceps had its set screw missing.Loss of the set screw may be the result of wear to the threading due to use or damage during disassembly.No manufacturing, workmanship or material deficiency has been identified.The reported complaint was confirmed.Trends will be monitored for this and similar issues.

• Brand Name: CRILE FCPS 6-1/4 CVD MATTE
• Common Device Name: N/A
• 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: 16989717
• Report Number: 3014334038-2023-00067
• Device Sequence Number: 6163738
• Product Code: HRQ
• UDI-Device Identifier: 10381780179467
• UDI-Public: 10381780179467
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 06/12/2023

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: 107141
• Device Catalogue Number: 107141
• Device Lot Number: AF2212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/12/2023
• Date Device Manufactured: 12/01/2022
• 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