MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SUPERCUT METZENBAUM SCS 7 CVD; CARDIOVASCULAR SCISSORS

Model Number	100262
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the curved metzenbaum supercut scissor (102122) broke during a case for knee arthroscopy with multiple ligament repairs with allografts.While cutting soft tissue, the shaft of the handle near the lockbox broke and flew back, and nearly hit the surgeon in the face.The staff irrigated heavily to make sure all small pieces were removed.It was reported that no part of the instrument fell into the surgical site that could be seen with the normal eye.An x-ray was performed multiple times.There was a surgical delay of 30 minutes, as the staff had to stop to address the issue.The nurse obtained another pair of metzenbaum scissor.It was reported that the patient's outcome was great, although patient had to endure extra minutes of anesthesia and more doses of radiation that was planned for.
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.
Additional Manufacturer Narrative
Metzenbaum scissor supercut, curved, 7¿ (102122 ) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The curved metzenbaum supercut scissor (102122) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies related to the reported complaint were identified.Failure analysis - the investigation of the unit confirmed the complaint: the scissors were in used condition with the handle snapped off due to rough handling/environmental damage.Root cause - the reported complaint is confirmed.The scissors were in used condition with the handle snapped off due to rough handling/environmental damage.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: SUPERCUT METZENBAUM SCS 7 CVD
• Common Device Name: CARDIOVASCULAR SCISSORS
• 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: 13498296
• Report Number: 3014334038-2022-00015
• Device Sequence Number: 11880017
• Product Code: DWS
• UDI-Device Identifier: 10381780432517
• UDI-Public: 10381780432517
• 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,Followup
• Report Date (Section B): 04/21/2022

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 Model Number: 100262
• Device Catalogue Number: 102122
• Device Lot Number: AA1902
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 03/29/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/08/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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