MAUDE Adverse Event Report: AESCULAP AG TC HALSEY NEEDLE HOLDER SERR 130MM; BASIC INSTRUMENTS

Model Number BM012R

Device Problem Break (1069)

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

Event Date 06/06/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with bm012r - tc halsey needle holder serr 130mm.According to the complaint description, the tip of the tungsten carbide broke off in patient.This occurred during a hand procedure, and the piece was retrieved successfully.An additional medical intervention was required.Additional information was not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: investigator carried out the pictorial documentation visually and microscopically.The needle holder is in a worn condition, one tungsten carbide inlay is broken, the fragment is not present for examination.The fracture surface of shows no abnormalities like blowholes of foreign particle inclusions.Due to the small dimension/diameter of the device, a detailed fracture surface analysis is difficult.Due to that circumstance there are no clear hints regarding arrestlines (hints for fatigue fracture) or clearly signs of a forced fracture.Device history records: due to the fact, that no lot number was provided, a review of the device history records for the complained device is not possible.The current failure rate is within the risk analysis and therefore acceptable; severity was 4(5) and probability was 1(5).Explation and rationale: the cause of the breakage may be damage caused by a fall of the product.The tungsten carbide inlays have the property of being very brittle, which is why they are more sensitive to such forces.Conclusion/preventive measures: based upon the above mentioned investigation results, a definitive root cause for the reported issue could not be established.Based upon the investigation results, a capa is not necessary.

• Brand Name: TC HALSEY NEEDLE HOLDER SERR 130MM
• Type of Device: BASIC INSTRUMENTS
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17812817
• MDR Text Key: 324189526
• Report Number: 9610612-2023-00206
• Device Sequence Number: 1
• Product Code: HXK
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2023

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: BM012R
• Device Catalogue Number: BM012R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/25/2023
• 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