MAUDE Adverse Event Report: SKLAR INSTRUMENTS ECONO STERILE¿; ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50,

Model Number	96-2549
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not used on any patient.Problem noticed during incoming inspection.
Event or Problem Description
On (b)(6) 2025, one of sklar's distributors reached out to customer service regarding an issue with a hole in the sterile packaging of 1 ea of 96-2549 econo sterile¿ rochester-pean forceps, curved, 8 1/2" cs/50.This was noted on incoming inspection.The device was not used on any patient.

• Brand Name: ECONO STERILE¿
• Common Device Name: ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50,
• Manufacturer (Section D): SKLAR INSTRUMENTS; 1333 lenape rd.; west chester PA 19382
• Manufacturer Contact: douglas kraemer ; 1333 lenape rd.; west chester, PA 19382 ; 6104303200
• MDR Report Key: 22730949
• Report Number: 2431166-2025-00009
• Device Sequence Number: 9051122
• Product Code: GEN
• UDI-Device Identifier: 10649111056802
• UDI-Public: (01)10649111056802(17)20280323(10)600031
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: Other
• Device Model Number: 96-2549
• Device Catalogue Number: 96-2549
• Device Lot Number: 600031
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown