MAUDE Adverse Event Report: AESCULAP AG KERRISON 15MM NOIR 130DEG UP 200MM 2MM; PUNCH, SURGICAL

Model Number	FK970B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a kerrison 15mm noir 130deg up 200mm 2mm (material # fk970b) was used during a procedure performed on (b)(6) 2023.According to the complainant, the device became stuck after taking a bone bite.Reportedly, the physician encountered physical resistance while attempting to actuate the handle, which required him to use two (2) hands to forcibly release and retrieve the bone specimen.Prior to taking the bite, the handle functioned properly with smooth actuation noted.However, after taking the bone bite, the device jammed.Additional medical intervention was necessary to retrieve the dislodged bone fragment.The complaint device has been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing site evaluation: we received five bone stamps for examination, one had the tip bent upwards.Investigation result: the function test with an empty bone punch was positive for all of them - this means that the bone punches could be operated without problems and the upper slide moved back into its original position.The cutting test also complied with the specifications of the test plan, with the exception of the tool with the bent-up tip, which also did not jam.Conclusion root cause analysis description root cause: the error regarding the customer complaint cannot be confirmed - the bone punches are working according to the specification.Please pay attention to the ifu (fig.4).We can exclude a production-related cause based on the current analysis results.Details on root cause: n/a.Device history record review results of review device history records (dhr): the device quality and manufacturing history records (dhr) have been checked for this product and found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.
Event or Problem Description
Investigation complete.

• Brand Name: KERRISON 15MM NOIR 130DEG UP 200MM 2MM
• Common Device Name: PUNCH, SURGICAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17119811
• Report Number: 2916714-2023-00074
• Device Sequence Number: 17790481
• Product Code: LRY
• UDI-Device Identifier: 04046963166571
• UDI-Public: 4046963166571
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023
• Report Date (Section F): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FK970B
• Device Catalogue Number: FK970B
• Device Lot Number: 4513792617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/15/2023