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

Hold vm it was reported to aesculap inc.That an 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 # 2916714-2024-00072.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: d4 - batch number.Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: 19114649
• MDR Text Key: 340237844
• Report Number: 2916714-2024-00073
• 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
• Was Device Available for Evaluation?: No
• 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