MAUDE Adverse Event Report: AESCULAP AG LIGATURE CUTTER L:125MM; DENTAL

Model Number DP511R

Device Problem Break (1069)

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

Event Type  Injury  

Event Description

It was reported that there was an issue with dp511r - ligature cutter l:125mm.According to the complaint description, the cutter broke off in the patient's mouth.An additional medical intervention was required.The piece was removed from the throat.Further details were not provided.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: visual investigation: the microscopic examination has shown that the complete carbide insert has broken out of the working end of the instrument.Both breakage surfaces show clearly visible solder residues.In addition, the instrument as well as the broken-out carbide insert were subjected to a hardness measurement with the result that there are no deviations from the target values.No abnormalities could be detected in this respect.Batch history review: the device quality and manufacturing history records (dhr) will be checked for all leading device(s) lot numbers from the quality coordinator of the product plant.The results of the review will be documented within the complaint; if the review shows any conspicuities, the report will be updated and actions will be initiated.The review of risk assessment revealed that the overall risk level ((4)5 severity x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: due to the fact that this instrument was produced in 2014, the product has undergone many application cycles as well as maintenance cycles.We assume that due to recurring high load situations and possible overloading, the carbide inlay finally broke out on one side.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem cannot clearly be determined.There is no indication for a material or design-related failure.Based upon the investigation results, a capa is not necessary.

• Brand Name: LIGATURE CUTTER L:125MM
• Type of Device: DENTAL
• 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: 15456749
• MDR Text Key: 300257950
• Report Number: 9610612-2022-00277
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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: DP511R
• Device Catalogue Number: DP511R
• Device Lot Number: 4505883915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2014
• 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