MAUDE Adverse Event Report: AESCULAP AG TC MAYO-HEGAR NDL HOLDERHVYSERR205MM; DUROGRIP NEEDLEHOLDERS

Model Number	BM067R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.Medwatch report # 450015000-2021-8015.
Event or Problem Description
It was reported that there was an issue with bm067r - tc mayo-hegar ndl holderhvyserr205mm.According to the complaint description, during cesarean section procedure part of a needle driver insert fell into a patient.An additional medical intervention was necessary.The adverse event is filed under (b)(4) reference (b)(4).
Event or Problem Description
Clarification was received: there was no delay caused by the breakage in the original surgery.However, postoperatively, the patient underwent another procedure (not specified), as well as attending multiple physician appointments, and required the performance of additional x-rays.
Additional Manufacturer Narrative
B5 - description updated.H6 - updated codes.
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: TC MAYO-HEGAR NDL HOLDERHVYSERR205MM
• Common Device Name: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12739301
• Report Number: 2916714-2021-00213
• Device Sequence Number: 4774693
• Product Code: HXK
• UDI-Device Identifier: 04038653028276
• UDI-Public: 4038653028276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2021
• Report Date (Section F): 10/29/2021

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: BM067R
• Device Catalogue Number: BM067R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/06/2021; 12/23/2021
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 176 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 10/29/2021