MAUDE Adverse Event Report: AESCULAP AG KERRISON DETACH 130DG UP 200MM 1MM THIN; BONE PUNCHES

Model Number	FK961B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with fk961b-kerrison detach 130dg up 200mm 1mm thin.The tip of the device broke during use in a c4-c6 anterior cervical discectomy and fusion (acdf) procedure.The broken fragment was successfully retrieved from the patient as the piece was easily visible.An x-ray was not required; there was less than 5 minute delay required to replace the instrument.An additional medical intervention was necessary.The fragment was noted to be extremely small.Additional information was not provided nor available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Updated d4: lot number.H4- manufacture date.Updated h6: codes.Investigation results: visual investigation: product available for investigation in a decontaminated condition.The kerrison punch shows a broken footplate.Vigilance investigator carried out the pictorial documentation visually and microscopically.The footplate is totally broken off.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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 DETACH 130DG UP 200MM 1MM THIN
• Common Device Name: BONE PUNCHES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11863728
• Report Number: 9610612-2021-00437
• Device Sequence Number: 14556330
• Product Code: LRY
• UDI-Device Identifier: 04038653436811
• UDI-Public: 4038653436811
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: FK961B
• Device Catalogue Number: FK961B
• Device Lot Number: 4510458720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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