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

Model Number BM012R

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

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

Event 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).

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 Description

Investigation complete.

• Brand Name: TC HALSEY NEEDLE HOLDER SERR 130MM
• Type of Device: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17199554
• MDR Text Key: 317987753
• Report Number: 2916714-2023-00080
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653027903
• UDI-Public: 4038653027903
• 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,Followup
• Report Date: 06/26/2023,09/25/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2023
• Distributor Facility Aware Date: 06/07/2023
• Device Age: 176 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention