MAUDE Adverse Event Report: AESCULAP AG EXTRA LONG-SIZE PERF.BASKET TALLER HDL.; STERILE TECHNOLOGY

Model Number JF532R

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2020

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 perforated basket.According to the complaint description while the tray has been in service they have been seeing black specs in the sets and the or is immediately sending them back down to central processing.The black specs seem to be coming from the bottom of the basket and the screws rubbing up onto the black retention plate.The failure occurred and there was a 5-10 minute surgery delay during preparation.There was no harm to patient.Additional information has been requested but no provided to date.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: jn445 - extra long container perf bottom 187mm - batch unknown.Jg303r - screw set - batch unknown.

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: EXTRA LONG-SIZE PERF.BASKET TALLER HDL.
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10346914
• MDR Text Key: 207955059
• Report Number: 9610612-2020-00339
• Device Sequence Number: 1
• Product Code: FSM
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF532R
• Device Catalogue Number: JF532R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JG303R - SCREW SET.; JN445.