MAUDE Adverse Event Report: A&E MEDICAL CORPORATION RSP 3.5MM 6BOX ST; PUNCH, SURGICAL

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).G2: foreign source: japan 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.
Event or Problem Description
It was reported during the incoming inspection at a warehouse, a team member found a a foreign substance in the package.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h4, h6, h10, h11 no product was returned.For 080-351 lot 24993 there appears to be a reddish debris inside of the package.It cannot be determined what the debris is.No hair is visible in the picture.The most likely root cause is the hair/ debris entering the package during the packaging process.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the provided work instructions during manufacturing.The reported event is confirmed, based on provided photos.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.

• Brand Name: RSP 3.5MM 6BOX ST
• Common Device Name: PUNCH, SURGICAL
• 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: 20545578
• Report Number: 0002242056-2024-00030
• Device Sequence Number: 18111174
• Product Code: LRY
• UDI-Device Identifier: 20841291105142
• UDI-Public: (01)20841291105142(10)24993(17)290601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: N/A
• Device Catalogue Number: 080-351
• Device Lot Number: 24993
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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