MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NON-CAT SCREW FOR 300-253 BLADES/ARMS; N/A

Model Number	300SRW253
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2023
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
The following was reported via medwatch uf/importer report #(b)(4): "morse retractor broke while being used to hold open patient's sternum.Screw and attachment piece broke off." original intended procedure: emergent aortic valve replacement.It was subsequently reported that the screws and the metal piece that broke off fell into the surgical site.The fragments were removed by the doctor's hands; all broken parts were recovered.An x-ray was obtained to assure no parts were left in patient; no fragments were found.It was reported that the patient was under anesthesia at the time of the event.There was a 5-10 minute delay of surgery due to the product problem.There was no injury to the patient.No medical intervention was required.Staff obtained a new morse retractor; once all pieces were removed, the surgeon continued the case as normal.It was reported that the device was sent to the facility's reprocessing department for repair.
Additional Manufacturer Narrative
The non-cat screw for 300-253 blades/arms (300srw253) was not returned; therefore, an evaluation of the device could not be performed.Lot number information has not been provided and thus, the device history record (dhr) could not be reviewed.A definitive root cause could not be determined.The issue of breaking may be the result of excessive force or environmental damage to the blades.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.

• Brand Name: NON-CAT SCREW FOR 300-253 BLADES/ARMS
• 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: 17076448
• Report Number: 3014334038-2023-00082
• Device Sequence Number: 2212933
• Product Code: GAD
• UDI-Device Identifier: 10381780457091
• UDI-Public: 10381780457091
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 300SRW253
• Device Catalogue Number: 300SRW253
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/26/2023
• 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 Age: 73 YR
• Patient Sex: Male