MAUDE Adverse Event Report: AESCULAP AG ADSON RETRACTOR SEMI-SHARP 4X4T.210MM; INSTRUMENTS FOR NEUROSURGERY

Model Number BV251R

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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 jk100 - filter retention plate.According to the complaint description, a piece of the retractor broke.This malfunction occurred during a femoropopliteal bypass procedure.There was no described patient harm, surgical delay, nor intervention required.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Event Description

Clarification: the malfunction occurred with an adson retractor semi-sharp, bv251r.

Manufacturer Narrative

Additional information/correction: according to review of the investigation, this event is considered no longer reportable for the following reason: the failure mode risk analysis has been adjusted to severity of 2(5).Investigation: visual investigation: the corrosion on the products is a so-called "stress corrosion" caused in combination with a mechanical tension.This type of corrosion often affects areas or components that have been subjected to tensile stress.This can be due to design limitations such as screw connections.Reprocessing of the instrument in a state of high heat can speed up the defect.Instruments with hairline cracks in the joint areas, as well as those that are damaged, distorted or otherwise worn, must be replaced because their function can no longer be fully or adequately guaranteed.Batch history review: the device quality and manufacturing history records (dhr) have been checked for the leading device(s) lot number(s) and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2(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, the root cause is most probably reprocessing-related.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results, a capa is not necessary.

• Brand Name: ADSON RETRACTOR SEMI-SHARP 4X4T.210MM
• Type of Device: INSTRUMENTS FOR NEUROSURGERY
• 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: 13579872
• MDR Text Key: 288805843
• Report Number: 9610612-2022-00034
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BV251R
• Device Catalogue Number: BV251R
• Device Lot Number: 4511345793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• 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