MAUDE Adverse Event Report: AESCULAP AG ROETTGEN-RUSKIN BONE RONGEUR 240MM; GENERAL SURGICAL INSTRUMENTS

Model Number FO521R

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2022

Event Type  Injury  

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 fo521r - roettgen-ruskin bone rongeur 240mm.According to the complaint description, the microscrew came loose from a luer clamp during the initial unspecified surgery.The patient then presented to a consultation on (b)(6) 2022 and x-ray results showed the presence of a screw-like mass in situ.A revision surgery was necessary to remove the foreign body.The patient was noted to be doing well.Additional information has been requested.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: d4 - batch number d9 - product receipt date h4 - manufacture date h6 - codes investigation results: instrument provided is in a used condition, and a labeling of a third party repair can be found.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) and probability 1(5)) according to din en iso 14971 is still acceptable; the current failure rate is within the risk analysis and therefore acceptable.Explanation and rationale: due to the third party maintenance, we cannot longer guarantee the quality requirements of the clamp.Most probably the worn joints and furthermore the improper repair caused the mentioned loosening of the screw conclusion and measures / preventive measures: based upon the investigation resulsts, a root cause cannot be finally concluded, but is most probably maintenance related.Based upon the investigations results a capa is not necessary.

• Brand Name: ROETTGEN-RUSKIN BONE RONGEUR 240MM
• 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: 15916091
• MDR Text Key: 304811174
• Report Number: 9610612-2022-00357
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FO521R
• Device Catalogue Number: FO521R
• Device Lot Number: 4507032953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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
• Patient Outcome(s): Required Intervention