MAUDE Adverse Event Report: AESCULAP AG TC DE'BAKEY NDL HOLDER DEL SERR 260MM; BASIC INSTRUMENTS

Model Number BM037R

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with bm037r - tc de'bakey ndl holder del serr 260mm.According to the complaint description, the tip of the device was damaged during surgery.The instrument was used during cardiac surgery.There was no described patient harm.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the product arrived in a clean status with a marked jaw and broken carbide insert.The investigation was carried out visually and microscopically.Here we found a marked jaw and a broken off carbide insert.Additionally we detected brown discoloration and unknown deposits.Furthermore we made a visual inspection of the fracture surface.No anomalies were discovered.Investigations lead to the assumption that the crack was caused due to a stress-corrosion cracking.The brown discoloration could be corrosion.Due to an existing pre-damage or weak point, the reprocessing was breakage-triggering.There is the possibility for a pre-damage due to a mechanical overload situation or an excessive force.This could also be the cause for the broken off carbide insert.The exact cause could not be determined.Batch history review: batch history review is not yet available.In our regular system the device quality and manufacturing history records are not available for such old manufacturing dates regarding this manufacturing date.Therefore the dhr will be checked by the responsible manufacturing department at that time.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: TC DE'BAKEY NDL HOLDER DEL SERR 260MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11653127
• MDR Text Key: 251239109
• Report Number: 9610612-2021-00296
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653028115
• UDI-Public: 4038653028115
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM037R
• Device Catalogue Number: BM037R
• Device Lot Number: 4502443935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1