MAUDE Adverse Event Report: AESCULAP AG KERRISON BLK COATED 130 UP 180X1MM THIN; BONE PUNCHES, RONGEURS

Model Number FK906B

Device Problem Material Fragmentation (1261)

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

Event Date 05/05/2021

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 fk906b - kerrison blk coated 130 up 180x1mm thin as per information received via medwatch (b)(4).According to the complaint description, rongeur was in use during surgery, doctor noticed the tip was loosened.The tip did not break off completely until in the possession of the riks coordinator.An additional rongeur was used to complete the surgery.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

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.

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.After receipt of device a detailed investigation was carried out.Investigation results: visual investigation: the product arrived in a clean status with a broken off foot plate.The broken off part is missing.Investigation was carried out visually and microscopically.Here we found a broken off footplate.Additionally we found unknown deposits and a visible used cutting edge of the part wangler.Furthermore we made an optical inspection of the fracture surface.No anomalies were detected.According to the quality standard and dhr files a material defect and production error can be excluded.No pores or inclusions could be found on the point of rupture.Investigations lead to the assumption that breakage was caused due to an improper handling by a mechanical overload situation.This could have been caused by levering or turning movement with the instrument.This led to a broken off footplate and there is also the possibility for pre-damage or similar due to previous surgeries by overstraining.The product is for delicate use only.Furthermore according the instruction for use the following points and warning must be observed: "kerrison bone punches with thin footplate are marked with a gold-colored distal working end or gold-colored front handle and the label "for delicate use only"." (excerpt of the instruction for use (ifu) ta010668, 2020-07 v6, change no.62004).Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.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 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: KERRISON BLK COATED 130 UP 180X1MM THIN
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12033747
• MDR Text Key: 266233792
• Report Number: 9610612-2021-00445
• Device Sequence Number: 1
• Product Code: LRY
• UDI-Device Identifier: 04038653405459
• UDI-Public: 4038653405459
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK906B
• Device Catalogue Number: FK906B
• Device Lot Number: 1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1002600000-2021-8005
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 73