MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	8360-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
According to the event description: a prestige atra grasper dbl-act 5mm (part # 8360-10) fractured causing one of the jaws and two other pieces to fall inside of a patient.The instrument was removed and intervention was needed to collect the pieces and an xray was taken to confirm all pieces had been retrieved in the patient.Reportedly there was a ten minute delay to the procedure.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).One (1) sample was provided for technical evaluation.The results of the investigation confirmed that the body of the product has both jaws detached.The sample was received with jaws and both links in a separate bag within the returned package.The spacer is still assembled within the sample body.Geometry of the articulating link pins shows disassembly, not breaking.This product may have been reserviced due to the following evidence: the 8360-10801 insulation is not an oem part, but a replacement part, as identified by the texture.The spring/button combination has been fixed onto 8360-10804 handle assembly with a set screw.During investigation, the spacer separated from the body of the complaint device.Based on the investigation findings, the manufacturing site is aware of this issue and has entered this complaint into our trending report.An approved project was initiated to address the issue of this nature.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22001924
• Report Number: 2916714-2025-00018
• Device Sequence Number: 9164271
• Product Code: NBH
• UDI-Device Identifier: 00885554016161
• UDI-Public: (01)00885554016161(10)50687282
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: 50687282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown