MAUDE Adverse Event Report: AESCULAP AG CRILE FORCEPS CVD 140MM; GENERAL SURGICAL INSTRUMENTS

Model Number BH145R

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); 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 bh145r - crile forceps cvd 140mm.According to the complaint description, the criles broke.Patient harm was unknown.Additional information was requested.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: bh145r (9610612-2022-00258) (b)(4).

Manufacturer Narrative

Updated h6 codes based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: we made a visual inspection of the product.Here we found the broken instrument on the jaw male.Here we detected brown and dark discolorations and signs of an intercrystalline fracture.The cause of the damage is due to several factors that have led to the fracture.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that two similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: investigations lead to the assumption that the breakage was caused by stress-corrosion cracking.Possibly a pre-damage could caused due to a manufacturing deviation by unfavorable production-related circumstances, such as sharp-edged milling transitions, as well as critical material tensile stress conditions due to straightening work.It appears that the brown discolorations are rust / corrosion and the dark discoloration are signs of an old crack.Additionally it appears that the cracks are ferrite rusticities / ferrite microstructures.Due to the existing pre-damage or weak point, the reprocessing was fracture-triggering.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue is most probably reprocessing - related, or manufacturing, or design-related failure.Based upon the investigations results a change request was initiated.

Event Description

Associated medwatch reports: bh145r (9610612-2022-00258) (b)(4).

• Brand Name: CRILE FORCEPS CVD 140MM
• 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: 15441890
• MDR Text Key: 305155147
• Report Number: 9610612-2022-00273
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BH145R
• Device Catalogue Number: BH145R
• Device Lot Number: 4509467140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2018
• 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