MAUDE Adverse Event Report: AESCULAP AG KERRISON BLK COATED 130 UP 180X1MM THIN; BONE PUNCHES

Model Number	FK906B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility report # (b)(4).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
It was reported to aesculap inc.That a kerrison blk coated 130 up 180x1mm thin (part # fk906b) was used during a c5-c7 anterior cervical disc fusion procedure performed on an unknown date.According to the complainant, during the surgery, the tip of the kerrison broke off.The physician found and retrieved the device fragments, and then continued and successfully completed the procedure without any further issues.The complaint device was not available to be returned to the manufacturer for evaluation.No adverse patient effects were reported as a result of the event.Although requested, additional information has not been made available.The adverse event is filed under (b)(4).
Event or Problem Description
No updates required.
Additional Manufacturer Narrative
Corrected information - block b3 manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
User facility report #(b)(4).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 3(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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
Event or Problem Description
No updates required.

• Brand Name: KERRISON BLK COATED 130 UP 180X1MM THIN
• Common Device Name: BONE PUNCHES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12359631
• Report Number: 2916714-2021-00181
• Device Sequence Number: 14401540
• Product Code: LRY
• UDI-Device Identifier: 04038653405459
• UDI-Public: 4038653405459
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021
• Report Date (Section F): 08/24/2021

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: FK906B
• Device Catalogue Number: FK906B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/22/2021; 12/16/2021
• 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 Age: 50 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/24/2021