MAUDE Adverse Event Report: AESCULAP AG KERRISON DET130 DEG UP 4MM 200MMREG; PUNCH, SURGICAL

Model Number	FK915R
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a kerrison det130 deg up 4mm 200mmreg (part # fk915r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the kerrison tip bent.Follow-up information was received on (b)(6) 2021 which revealed that the patient was injured during the procedure.Reportedly, a "dural tear" occurred that the surgeon had to patch.The complaint device was returned to the manufacturer for evaluation.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.
Event or Problem Description
Additional information: a surgical delay of approximately thirty (30) minutes was reported.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the products arrived in a used condition.The investigation was carried out visually and microscopically with the digital microscope and the digital-camera.Reference (b)(4): we made a visual inspection of the product, here we detected a deformed tip of the product.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.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 4MM 200MMREG
• Common Device Name: PUNCH, SURGICAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen 78501
• MDR Report Key: 12782830
• Report Number: 2916714-2021-00215
• Device Sequence Number: 14958903
• Product Code: LRY
• UDI-Device Identifier: 04041906113308
• UDI-Public: 4041906113308
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022
• Report Date (Section F): 11/09/2021

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: FK915R
• Device Catalogue Number: FK915R
• Device Lot Number: 4512227279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 03/23/2022
• 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: 11/09/2021