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

Model Number	080-402
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device has been returned to a&e medical.Device was observed to be contaminated with residue appearing to be blood.Distributor indicated no patient involvement.Unable to confirm lot number used from distributor, however after inspection of sales records it was determined to be (b)(4).Follow-up report will be issued once device returns from sterilizer which will conclude investigation and complete reporting.
Event or Problem Description
Complaint received indicates plastic material was found adhered to the pin of the surgical punch.Distributor indicated no patient involvement.
Additional Manufacturer Narrative
Complaint received indicated plastic material was found adhered to the pin tip of the surgical punch by a clinician.Suspect device was returned to a&e medical for investigation.Distributor indicated no patient involvement.Unable to confirm lot number from the distributor, however, after inspection of sales records it was determined to be either 135, 136 or 137.An initial fda mdr form detailing preliminary findings and observations was provided to the fda.The device was contaminated with residue appearing to be blood thus further investigation had to be continued after the device was cleaned and sterilized.This follow-up report concludes the investigation.The complaint was confirmed as plastic material was found attached to the pin of the surgical punch.It is believed the media found on the punch pin tip was excess plastic material which adhered to the tip during the hole punch test at the final assembly step.Historically visual inspection has always been performed by the operators after the hole punch test.Dop (b)(4) surgical punch final assembly and inspection was revised to reflect the practice of visual inspection of the pin tip after the hole punch test to ensure no test media remains.The instructions included use of tweezers and compressed air to ensure material is removed after punch test.Relevant personnel were retrained to the latest revision.Reference (b)(4).Rotating surgical punch risk management documentation, fmea-12p001 and rmr12001, were revised to include the risk of test media adhering to the pin after punch test during final inspection along with revising the risk "benefit" analysis.Reference (b)(4).
Event or Problem Description
Complaint received indicated plastic material was found adhered to the pin tip of the surgical punch by a clinician.Suspect device was returned to a&e medical for investigation.Distributor indicated no patient involvement.Unable to confirm lot number from the distributor, however, after inspection of sales records it was determined to be either 135, 136 or 137.An initial fda mdr form detailing preliminary findings and observations was provided to the fda.The device was contaminated with residue appearing to be blood thus further investigation had to be continued after the device was cleaned and sterilized.This follow-up report concludes investigation.

• Brand Name: ROTATING SURGICAL PUNCH
• Common Device Name: SURGICAL PUNCH
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 8601567
• Report Number: 2242056-2019-00003
• Device Sequence Number: 2075211
• Product Code: LRY
• UDI-Device Identifier: 20841291105173
• UDI-Public: 20841291105173
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 080-402
• Device Catalogue Number: 080-402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1