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

Model Number	080-351
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A&e completed a full investigation of a similar complaint and the summary of findings is attached.Current punch production tests all punches for cut and activation prior to packaging.Complaints for failing to cut as expected are very low (based on the review of sales and the number of complaints (6), rate of failure is less than (b)(4)).None of the complaints indicate patient safety risk.Users continue to use product without further issue, again indicating the isolated nature of these complaints.Based on the investigation in attached summary, improvements to production process are being implemented.
Event or Problem Description
While using the punch, it did not cut as it should.

• Brand Name: A&E MEDICAL ROTATING SURGICAL PUNCH
• Common Device Name: SURGICAL PUNCH
• Manufacturer (Section D): A&E MEDICAL; 5206 asbury rd; po box 758; farmingdale NJ 07727
• MDR Report Key: 10554512
• Report Number: 2242056-2020-00005
• Device Sequence Number: 3749711
• Product Code: LRY
• UDI-Device Identifier: 20841291105142
• UDI-Public: (01)20841291105142(10)0263P(17)240701
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/18/2020

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: 07/01/2024
• Device Model Number: 080-351
• Device Lot Number: 0263P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1