MAUDE Adverse Event Report: AESCULAP AG KERRISON DET130 DEG UP 3MM 280MM; BONE PUNCHES, RONGEURS

Model Number	FK987R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with fk987r-kerrison det130 deg up 3mm 280mm.It was reported that the top of the kerrison det130 deg up 3mm 280mm device's cutting edge (the lip across the sharp cutting surface that goes against the footplate) bent back during a laminectomy procedure on (b)(6) 2020.This was reportedly the first time the device has been used.While an alternative device was readily available to complete the procedure and there was no surgical delay there is a concern as the devices seem like they cannot cut at all.The reported event did not cause or contribute to a serious injury or death.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information: updated h4: manufacturing date: updated h6: codes: based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: product available for investigation arrived in a decontaminated condition.The kerrison punch is showing a bent-up cutting edge and a damaged part on the upper slider part.Vigilance investigator carried out the pictorial documentation visually and microscopically.The punches show clear signs of deformation on the cutting edge of the upper slider, which is bent-up and additionally it shows a circular deformation.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 DET130 DEG UP 3MM 280MM
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10929478
• Report Number: 9610612-2020-00852
• Device Sequence Number: 11397709
• Product Code: LRY
• UDI-Device Identifier: 04046964508714
• UDI-Public: 4046964508714
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FK987R
• Device Catalogue Number: FK987R
• Device Lot Number: 4511310527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1