MAUDE Adverse Event Report: AESCULAP AG KERRISON DET130 DEG UP 2MM 200MMREG; BONE PUNCHES

Model Number	FK913R
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
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 to aesculap inc.That a kerrison det130 deg up 2mm 200mmreg (part # fk913r) was used during a lumbar discectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the distal tip of the upper sliding portion of the device was peeling (bending) backwards.The surgical staff opened a second set of instruments, which led to a delay of approximately ten (10) minutes, to successfully complete the procedure.The complaint device was returned to the manufacturer for evaluation.The incident did not cause or contribute to a serious injury or patient death.No additional medical intervention was required.Although requested, additional information has not been provided.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - d4 (batch number), corrected information - h4, h6 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: 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.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 2MM 200MMREG
• Common Device Name: BONE PUNCHES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11619621
• Report Number: 9610612-2021-00268
• Device Sequence Number: 4010333
• Product Code: LRY
• UDI-Device Identifier: 04038653299744
• UDI-Public: 4038653299744
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: FK913R
• Device Catalogue Number: FK913R
• Device Lot Number: 4511755005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1