MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-EDGE IRIS SCS 4-1/2 STR; N/A

Model Number	101300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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 carb-edge iris scissors (101300) was broken during use by the action of a small force.It was initially reported that the device was not in contact with the patient at the time it broke and was discovered broken after surgery.However, subsequent information was received reporting that the fracture occurred during the clamping in surgery.Reportedly, it took a while for staff to find a broken piece of instrument in the surgical site and a replacement instrument not already on the surgical set took time to prepare.An unspecified delay in surgery time occurred and the surgeon had to repeat the surgical procedure.To note, the apparatus was cleaned and disinfected according to prescribed protocol.The facility checked the cleaning, sterilization and management of the instrument, but no problems were found in the process.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The suspected carb-edge iris scissors (101300) was not returned for evaluation, after three good faith efforts (gfe) to obtain the product.Lot number was provided, device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.The product lot number indicates a manufacture date of 2019.The issue of breaking during use may be the result of wear or environmental damage over time.However, a definitive root cause could not be determined.
Additional Manufacturer Narrative
The carb-edge iris scissors (101300) was subsequently returned for evaluation: the carb-edge iris scissors was received in used condition with one of the tips broken off of due to rough handling/environmental damage.The product lot number indicates a manufacture date of 2019 and the sales order was sold in 2020, indicating damage may have occurred due to wear over two years of use.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: CARB-EDGE IRIS SCS 4-1/2 STR
• 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: 15933117
• Report Number: 3014334038-2022-00273
• Device Sequence Number: 4347240
• Product Code: HNF
• UDI-Device Identifier: 10381780375029
• UDI-Public: 10381780375029
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2023

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: 101300
• Device Catalogue Number: 101300
• Device Lot Number: AA1903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 01/18/2023; 02/22/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/31/2023; 03/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2019
• 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