MAUDE Adverse Event Report: AESCULAP AG TC MAYO-HEGAR NDLHOLDERHVYSERR150MM; GENERAL SURGICAL INSTRUMENTS

Model Number BM065R

Device Problem Product Quality Problem (1506)

Patient Problems No Known Impact Or Consequence To Patient (2692); 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 tc mayo-hegar ndlholder.It was reported that the needle holder have gaps in solder.However,we have no further information.There was no patient harm.This event/malfunction did not prolonged the surgery.Additional patient information is not available.(b)(4).

Manufacturer Narrative

General information due to covid19 circumstances, the product is was not sent for investigation, but pictures were provided by sales organization.Consequences for the patient according to the available information, there were no negative consequences for the patient.Investigation was carried out based on the pictures provided.Compared to the quality standard, the gap in the solder seam is not according to the specifications, the soldering must be completely filled.Batch history review.The traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.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 probably related to a manufacturing error.Rationale.Refer to investigation.The current failure rate is within the risk analysis and therefore acceptable.

Manufacturer Narrative

Visual investigation: the investigation was carried out visually.A gap was detected at the soldered seam.This does not comply with the quality standard, because solder joint must be filled completely.Batch history review: 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 3 (5) 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 of the reported issue can be traced back to a manufacturing-related failure.Based upon the investigations results the quality coordinator of the production plant will be informed and will initiate measures if necessary.

• Brand Name: TC MAYO-HEGAR NDLHOLDERHVYSERR150MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10174049
• MDR Text Key: 198185406
• Report Number: 9610612-2020-00219
• 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,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM065R
• Device Catalogue Number: BM065R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1