MAUDE Adverse Event Report: A&E MEDICAL CORPORATION ROTATING SURGICAL PUNCH

Model Number	080-403
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, the reported failure could not be confirmed; the customer did not have additional information on the event and was not able to return the device for evaluation.A review of the complaint history shows that there have been no prior complaints in the past 2 years reported regarding the punch failing to retract and requiring manual removal with a surgical blade.This results in a complaint rate of 0.0009% (1 complaint per 106,112 surgical punches sold in the past 24 month period from the date this complaint was reported).There have been no other issues reported for this product lot from other customers.Additionally, production has not reported any in-process issues or seen any changes with manufacturing.At this point in time, this event appears to be isolated and the root cause cannot be determined.Should additional information be provided, further investigation will be conducted.
Event or Problem Description
Aortic punch tip failed to retract requiring manual removal with surgical blade.

• Brand Name: ROTATING SURGICAL PUNCH
• Common Device Name: SURGICAL PUNCH
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; po box 758; farmingdale NJ 07727
• MDR Report Key: 11201752
• Report Number: 2242056-2021-00002
• Device Sequence Number: 16731831
• Product Code: LRY
• UDI-Device Identifier: 10841291105183
• UDI-Public: (01)10841291105183(10)00552(17)250101
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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 Expiration Date: 01/01/2025
• Device Model Number: 080-403
• Device Catalogue Number: 080-403
• Device Lot Number: 00552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 117