MAUDE Adverse Event Report: ALTO DEVELOPMENT CORPORATION A&E MEDICAL CORPORATION MYO / PUNCH; SURGICAL PUNCH

Catalog Number 080-481

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

An email correspondence was received stating the white end of the punch was separated from the handle and that there was a blue fleck of material observed under the cutter.During the investigation additional information indicated a second device was noted to have a blue fleck of material under the cutter.The blue fleck of material was wiped away from the device by the attending surgeon and this second device was utilized successfully in the procedure.

• Brand Name: A&E MEDICAL CORPORATION MYO / PUNCH
• Type of Device: SURGICAL PUNCH
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury rd.; farmingdale NJ 07727
• Manufacturer (Section G): ALTO DEVELOPMENT CORPORATION; 5206 asbury rd.; farmingdale NJ 07727
• Manufacturer Contact: bill kilby ; 5206 asbury rd.; farmingdale, NJ 07727 ; 7329382266
• MDR Report Key: 6167660
• MDR Text Key: 62377436
• Report Number: 2242056-2016-00010
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 080-481
• Device Lot Number: 0202P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention