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

Model Number BD511R

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  Injury  

Event 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 are breaking off during while grasping tissue.The adverse event is filed under aic reference (b)(4).Reference associated medwatch report # 2916714-2024-00073.

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

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
• Type of Device: FORCEPS (TWEEZERS)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19114648
• MDR Text Key: 340235799
• Report Number: 2916714-2024-00072
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 04038653023646
• UDI-Public: 4038653023646
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Model Number: BD511R
• Device Catalogue Number: BD511R
• Device Lot Number: 4509798915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2024
• Distributor Facility Aware Date: 03/21/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention