MAUDE Adverse Event Report: AESCULAP AG ADSON TISSUE FCPS FINE W/1X2T 120MM; FORCEPS (TWEEZERS)

Model Number	BD511R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a adson tissue fcps fine w/1x2t 120mm (part # bd511r) was used during an orthopedic procedure on (b)(6) 2024.According to the complainant the teeth of the device were breaking off while grasping tissue.The adverse event is filed under aic reference: (b)(4).
Additional Manufacturer Narrative
Additional information: d4 - batch and serial number.D9 - product return.F9 - approximate age of device.Investigation results: visual inspection: the teeth on two (2) products were broken off.For product three (3), no product was returned.Hardness test: actual: 491, 488 (hardness according to vickers) hv5.Target:400+100.Device history review: the device quality and manufacturing history records have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.There are no other similar complaints within these batches.Conclusion/preventive measures: based upon the above-mentioned investigation results, a definitive root cause cannot be established.There are no hints for a material failure, as the hardness is according to the specification; and a product related failure is also excluded.

• Brand Name: ADSON TISSUE FCPS FINE W/1X2T 120MM
• Common Device Name: FORCEPS (TWEEZERS)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19086573
• Report Number: 2916714-2024-00070
• Device Sequence Number: 7819823
• Product Code: HTD
• UDI-Device Identifier: 04038653023646
• UDI-Public: 4038653023646
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024
• Report Date (Section F): 04/11/2024

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: BD511R
• Device Catalogue Number: BD511R
• Device Lot Number: 4512649829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/21/2024
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/11/2024