MAUDE Adverse Event Report: AESCULAP AG TC BERRY STERNAL NEEDLE HOLDER 185MM; GENERAL SURGICAL INSTRUMENTS

Model Number MD456R

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.A gap in solder can be found at the working end.According to the qstd, the soldering must be complete filled and even batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.The review of risk assessment revealed that the overall risk level (severity 3(5) probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: according to the qstd, the soldering must be free of gaps.Therefore this needle holder should not have passed the final inspection.Since no similar complaint is listed in the system.Due to the facts we can excluded a systematically failure.Based on the investigations and results of the 8d report no capa is necessary.

Event Description

It was reported that there was an issue with md456r-tc berry sternal needle holder 185mm.According to the complainant, the instrument had deep gap in solder.Which is a decontamination issue.There was no described patient harm.Additional information was not provided nor available / was not available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).

• Brand Name: TC BERRY STERNAL NEEDLE HOLDER 185MM
• 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: 11426761
• MDR Text Key: 249483373
• Report Number: 9610612-2020-00890
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2021

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: MD456R
• Device Catalogue Number: MD456R
• Device Lot Number: 4511128397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1