MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*SKIN STAPLER-WIDE; REMOVABLE (SKIN)

Catalog Number	PXW35
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to a laceration closure the surgeon that the patient showed up in ed (b)(6) with a scalp laceration.Laceration was repaired with 3 staples from pxw35.Patient returned yesterday (b)(6) to have the staples and the staples were no longer visible.X-ray confirmed they were still present and had fully looped as the should.Patient went to the operating room for removal and after the wound was re-opened it was discovered that all 3 staples were embedded in the skull.
Additional Manufacturer Narrative
(b)(4) date sent 4/24/2025 d4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21900528
• Report Number: 3005075853-2025-02962
• Device Sequence Number: 12939757
• Product Code: GDT
• UDI-Device Identifier: 10705036002673
• UDI-Public: (01)10705036002673(17)291231(10)432D43
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PXW35
• Device Lot Number: 432D43
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown