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

Model Number FK906B

Device Problem Material Fragmentation (1261)

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

Event Date 06/30/2021

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 blk coated 130 up 180x1mm thin (part # fk906b) was used during a c5-c7 anterior cervical disc fusion procedure performed on (b)(6) 2021.According to the complainant, during the surgery, the tip of the kerrison broke off.The physician found and retrieved the device fragments, and then the procedure was continued and successfully completed 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) reference (b)(4).

Manufacturer Narrative

Corrected information - block b3.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

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.

• Brand Name: KERRISON BLK COATED 130 UP 180X1MM THIN
• Type of Device: BONE PUNCHES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12359089
• MDR Text Key: 267851576
• Report Number: 9610612-2021-00573
• Device Sequence Number: 1
• Product Code: LRY
• UDI-Device Identifier: 04038653405459
• UDI-Public: 4038653405459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK906B
• Device Catalogue Number: FK906B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR