MAUDE Adverse Event Report: B/ BRAUN SURGICAL SA TC MAYO-HEGAR NDL HOLDERHVYSERR205MM; BASIC INSTRUMENTS

Model Number BM067R

Device Problem Solder Joint Fracture (2324)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This is a preliminary report.Manufacturing site evaluation: up to now, the product is not available for investigation, but pictures were provided.Investigation: based on the provided pictures and the quality standards, the gaps in the solder are not according to the specifications."finish/soldering: evenly and completely filled soldering, thickness about 0.5 mm.Free of visually unobtrusive pores at the jaw, and elsewhere".Pictorial documentation: gap in solder, decontamination issue.Batch history review: the device quality and manufacturing history records for the available lot number have been requested from the responsible coordinator at the production plant.The answer is still pending and the report will be updated upon receipt of the document review.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most likely related to a manufacturing error.Rationale: the gaps in the solder are not according to specifications.Corrective action: the responsible parties at the production plant have been informed and a request made to initiate necessary measures to avoid this error in the future.

Event Description

It was reported that there was an issue with the mayo needle holder.During the quality check, the needle holder failed due to a malfunction.It was noted that there were gaps in the soldering.There was no patient harm or procedure involved.Additional information has been requested.

Manufacturer Narrative

Manufacturing site evaluation: the product was available for investigation uncontaminated.The needle holder is in mint condition.The mentioned gap in the solder at the working end can be recognized with the naked eye.The gap is approximately 0.6 mm long; according to quality documents, the solder must be free of gap: - to avoid customer complaints, the surface is free of visually unobtrusive oil residues.If applicable gaps and pores in the soldering - or rather welding seam, other pores, scratches, tool marks, or other contaminants/dirt and damage.Batch history review - the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - based on the information available as well as a result of our investigation the root cause of the failure is most likely related to a manufacturing error.Rationale - according to quality documents, the provided instrument is not according to the specifications valid at the time of production.Corrective action - a quality notification has been created to discuss this issue and initiate the necessary corrective actions.

• Brand Name: TC MAYO-HEGAR NDL HOLDERHVYSERR205MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8741305
• MDR Text Key: 149495331
• Report Number: 9610612-2019-00431
• Device Sequence Number: 1
• Product Code: HXK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM067R
• Device Catalogue Number: BM067R
• Device Lot Number: 4510082752
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1