MAUDE Adverse Event Report: AESCULAP AG TC HALSEY NEEDLE HOLDER SERR 130MM; DUROGRIP NEEDLEHOLDERS

Model Number	BM012R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a tc halsey needle holder serr 130mm (part# bm012r) was used during a hand procedure on june 6 2023.According to the complainant the tip of the device had broken off in the patient during the procedure.Additional information received confirmed that the broken piece was able to be retrieved from the patient.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Additional 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.
Event or Problem Description
Investigation complete.

• Brand Name: TC HALSEY NEEDLE HOLDER SERR 130MM
• Common Device Name: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17199554
• Report Number: 2916714-2023-00080
• Device Sequence Number: 20218979
• Product Code: HXK
• UDI-Device Identifier: 04038653027903
• UDI-Public: 4038653027903
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023
• Report Date (Section F): 06/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: BM012R
• Device Catalogue Number: BM012R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2023
• Device Age: 176 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 09/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2023