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  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product bd511r - adson tissue fcps fine w/1x2t 120mm.According to the complaint description, the teeth broke off while grasping tissue during orthopedic surgeries.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aesculap ag reference no.(b)(4) (aesculap ag reference no.(b)(4)).Associated medwatch-reports: (internal aesculap ag ref.No.(b)(4)) 9610612-2024-00114 (internal aesculap ag ref.No.(b)(4)) 9610612-2024-00115 (internal aesculap ag ref.No.(b)(4)).

Event Description

Associated medwatch-reports: 9610612-2024-00113 (internal aesculap ag ref.No.(b)(4) - bd511r).9610612-2024-00114 (internal aesculap ag ref.No.(b)(4) - bd511r).9610612-2024-00115 (internal aesculap ag ref.No.(b)(4) - bd511r).

Manufacturer Narrative

Additional information: d4 - batch and serial number.D9 - product return.H3 - yes, evaluation.H4 - manufacture date.H6 - codes updated.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.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered eportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19102252
• MDR Text Key: 340102451
• Report Number: 9610612-2024-00113
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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: 4512649829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention