MAUDE Adverse Event Report: AESCULAP AG TC DE'BAKEY NDL HOLDER DEL SERR 180MM; DUROGRIP NEEDLEHOLDERS

Model Number BM035R

Device Problem Material Fragmentation (1261)

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

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: 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 (b)(4) that a tc de'bakey ndl holder del serr 180mm (part # bm035r) was used during a cardiac surgery performed on (b)(6) 2021.According to the complainant, during the surgery, the needle holder broke.Reportedly, in the middle of the procedure, a part of the tungsten came off the mouth of the needle holder and detached into the patient.The fragment was retrieved from the patient.The complaint device was not returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aesculap (b)(4) reference (b)(4).

Manufacturer Narrative

H6 - codes updated.Investigation: 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 no lot number was provided, a review of the device history records for the complained device is not possible.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.According to the investigation results, a capa is not necessary.

• Brand Name: TC DE'BAKEY NDL HOLDER DEL SERR 180MM
• Type of Device: DUROGRIP NEEDLEHOLDERS
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13792936
• MDR Text Key: 288620094
• Report Number: 9610612-2022-00057
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653028092
• UDI-Public: 4038653028092
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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: BM035R
• Device Catalogue Number: BM035R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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