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

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4) g2: foreign - 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 that a foreign substance was found inside the packaging during a product inspection.There was no patient involvement.It was reported that no further information is available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned.A visual inspection was conducted on the customer provided picture.The picture shows a single piece of debris stuck to the product packaging.From the picture a determination cannot be made whether the debris is on the inside or the outside of the sterile packaging.As no product was returned measurements cannot be conducted to confirm if the debris is conforming or not as it could not be determined if the photo is to scale.Per procedure, the debris is to be measured with a calibrated tappi standard t564 (size estimation chart) if needed to estimate the size of the identified particles.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a manufacturing issue.Debris likely resulted from the manufacturing process as event was identified on unopened product but, our evaluation is limited as no product was returned and product acceptability for debris size and acceptability to established inspection criteria cannot be determined from supplied photos.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h4, h6 and h10.

• Brand Name: ROTATING SURGICAL PUNCH
• 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: 18431174
• Report Number: 0002242056-2024-00001
• Device Sequence Number: 7847055
• Product Code: LRY
• UDI-Device Identifier: 20841291105128
• UDI-Public: (01)20841291105128(10)1319(17)280501
• 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): 03/28/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 080-271
• Device Lot Number: 13139
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown