MAUDE Adverse Event Report: AESCULAP AG KERRISON DET130 DEG UP 1MM 180MMTHP; BONE PUNCHES, RONGEURS

Model Number FK906R

Device Problem Material Fragmentation (1261)

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

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That a kerrison det130 deg up 1mm 180mmthp (item # fk906r) was used in anterior cervical discectomy and fusion (acdf) procedure on (b)(6) 2022.According to the complainant, during a procedure the tip of the device broke off.X-ray was used to retrieve the broken metal tip from the patient.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.However, a surgical delay of fifteen (15) minutes was noted.The adverse event / malfunction is filed under aic reference (b)(6) 2022.

Manufacturer Narrative

Additional information - d4 (lot #) f9 (approximate age of device) manufacturing site evaluation: 1.Description of defect information received: io break - instrument.Sample product availability: yes.Sample product quantity: 1 piece(s).2.Investigation 2.1 sample description.The product was submitted to us for examination in a used, decontaminated condition with visible signs of use and a broken working end.A repair stamp indicates that the instrument was repaired in 2018.2.2 investigation method.[x] visual testing standard / specification: zooming/ pictorial documentation.Reference no.: n/a test equipment name: digital microscope vhx-5000 keyence.Test equipment no.: 2000024840.[x] visual testing standard / specification: pictorial documentation.Reference no.: n/a.Test equipment name: digital-camera "panasonic dmc tz8.Test equipment no.: n/a.[x] mechanical.Testing standard / specification: hardness.Reference no.: n/a.Test equipment no.: id nr.38374.2.3 investigation result: visual inspection of the product revealed a broken working end of the product.The broken off part is not available to us for examination.The fracture surface shows a forced ductile bending fracture.The hardness measurement for the specification of 420+110 hv5 resulted in a value of 472 hv5 which corresponds to the specification.3.Conclusion root cause analysis description root cause: no discrepancies were found during the inspection of hardness and material.According to bdocs-aim-117211 "proof of performance kerrison bone punching", the cause is handling related due to overloading of the material and associated design.The working end of the bone stem was used beyond its stability limit whereby it broke off.4.Device history record results of review device history records (dhr): since a repair was performed and this was identified as the cause, a review of the device history records is not necessary.Description of deviations related to complaint: n/a 5.Corrective measures: decision for corrective measures: yes [ ] no [x].Description of corrective measures incl.Recommendations to customer, if applicable: n/a.6.Sales decision plant.Not accepted-report only.

Event Description

Investigation complete.

• Brand Name: KERRISON DET130 DEG UP 1MM 180MMTHP
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15896171
• MDR Text Key: 304630320
• Report Number: 2916714-2022-00112
• Device Sequence Number: 1
• Product Code: LRY
• UDI-Device Identifier: 04038653299690
• UDI-Public: 4038653299690
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022,09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK906R
• Device Catalogue Number: FK906R
• Device Lot Number: 52292124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2022
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 81 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention