MAUDE Adverse Event Report: A&E MEDICAL CORPORATION RSP 4.0MM 6BOX ST; AORTA PUNCH, SINGLE-USE

Catalog Number	080-401
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgical punch was unable to cut through tissue as intended and another punch was used to complete the procedure.Additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4) g2: taiwan customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4,g3, g6, h2, h3, h4, h6, h10 -no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.-review of the device history record(s) identified no deviations or anomalies during manufacturing.-a definitive root cause cannot be determined.The reported event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
A visual inspection was conducted on the returned punch.The punch was returned outside of the packaging and showed signs of attempted use including debris on the tip cutting surface.The plunger was pulled back and the cutting tip fully retracted into the punch body.The cutting action appears to be working as it should.The cap for the punch was fully seated when received.The cap was removed and re-installed and locked in place as designed.The complaint is unable to be confirmed.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RSP 4.0MM 6BOX ST
• Common Device Name: AORTA PUNCH, SINGLE-USE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17379732
• Report Number: 0002242056-2023-00023
• Device Sequence Number: 15007768
• Product Code: LRY
• UDI-Device Identifier: 20841291105166
• UDI-Public: (01)20841291105166(10)09419(17)280101
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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 Catalogue Number: 080-401
• Device Lot Number: 09419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 12/05/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/31/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown