MAUDE Adverse Event Report: AESCULAP AG TC NEEDLE HOLDER X-DEL SERR200MM; DUROGRIP NEEDLEHOLDERS

Model Number	BM026R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to medwatch user facility report (b)(4): 1st surgery [date redacted] - following an open ventral hernia repair, it was identified that one of the needle drivers used in the fascial closure of the abdomen was broken at the tip of the insert.The field was searched for this small piece.At the time it was identified, the fascia and above was closed.An x-ray was then obtained.The attending radiologist read that there was a 2 mm metallic density projecting over the right upper quadrant on ap radio-graph.On lateral radiograph, the metallic density is approximately 3.1 cm deep to the fascia and 7.0 cm from the skin surface.It was unclear if this was in the peritoneal cavity or in the extraperitoneal spaces which would determine the operative risk of re-exploration.A ct of the abdomen was obtained to help further localize the fragment and it was found to be likely in the retrorectus space.Risk and benefits discussion were held with the patient and she elected to undergo an exploratory surgery to remove the foreign body.2nd surgery 1 day later [date redacted]- the surgeon explored the lateral upper space of the right side of the abdomen near the neurovascular bundle in the right retrorectus space and identified the metallic fragment on the posterior sheath.A 1.5mm metal fragment was located on the posterior sheath below the mesh in the retrorectus space.The metal fragment corresponded to the missing piece from the broken instrument (needle driver.) the metal fragment was removed.An intra-operative x-ray confirmed no further metallic object seen.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: d9: product return date.Investigation results: on the basis of the attached picture, the following analysis was made: it was detected that the tungsten carbide insert was broken.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion/preventive measures: on the basis of the current information, a definite root cause cannot be determined.There is no indication for a material-, manufacturing- or design-related failure.

• Brand Name: TC NEEDLE HOLDER X-DEL SERR200MM
• Common Device Name: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19492908
• Report Number: 2916714-2024-00087
• Device Sequence Number: 20605461
• Product Code: KCT
• UDI-Device Identifier: 04038653028047
• UDI-Public: 04038653028047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024
• Report Date (Section F): 06/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: BM026R
• Device Catalogue Number: BM026R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/01/2024
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Date Report Sent to FDA: 06/06/2024