MAUDE Adverse Event Report: AESCULAP AG TC DE'BAKEY NDL HOLDER DEL SERR 180MM; GENERAL SURGICAL INSTRUMENTS

Model Number BM035R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/02/2023

Event Type  Injury  

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 bm035r - tc de'bakey ndl holder del serr 180mm.According to the complaint description, the jaw-broken and a piece of needle holder fell into the stomach of a patient during a caesarean section.A fluoroscopy was performed to find the metal piece but the surgery table was not adapted to the passage of the device.The patient was closed, transferred to an adapted table and then reopened with a call for surgical reinforcement.After performing the fluoroscopy, the presence of a 5 mm metal end of the needle holder was observed.Despite a very careful exploration for several hours, the metal tip was not found.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

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.The photo provided by the customer shows a needle holder, which shows an incomplete carbide inlay on one side.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.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 1(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: an examination from this picture is not possible, it does not show the part number, the damaged/broken surface and the overall condition of the instrument.At that time we assume that the mentioned failure is not manufacturing related.Due to our internal inspection the complained product did not left the company in such a condition.The root cause for the breakage could be: an overload situation.Fall on a hard surface/ground.Shipping damage.Transport damage.The tungsten carbide inlays have the property of being very brittle, which is why they are more sensitive to such forces.Unfortunately, due to a lack of data and without the product we cannot determine the exact root cause for the mentioned breakage.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Since we do not have more information and do not know exactly whether it is a needle holder from aesculap, the product risk analysis can only be evaluated to a limited extent.The carbide is produced by a sintering process and has a slightly ferromagnetic characteristic, which is not similar to a cromium steel.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 DE'BAKEY NDL HOLDER DEL SERR 180MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• 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: 16234273
• MDR Text Key: 308018280
• Report Number: 9610612-2023-00011
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2023

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: BM035R
• Device Catalogue Number: BM035R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/13/2023
• 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
• Patient Sex: Female