MAUDE Adverse Event Report: AESCULAP AG KERRISON THIN-FT 130DG-UP 1MM 180MM; BONE PUNCHES

Model Number FF771R

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was an issue with ff771r - kerrison thin-ft 130dg-up 1mm 180mm.According to the complaint description,during spine procedure the tip of instrument broke.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information - b5, d4 (lot #), d9, f9.Corrected data - h6.Investigation results: visual investigation: the product arrived in a used condition.The investigation was carried out visually and microscopically with the digital microscope and the digital-camera.The visual inspection of the product was done and detected a broken off tip.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(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.

Event Description

Followup information was received which revealed that an x-ray was performed.An additional medical intervention was necessary.

• Brand Name: KERRISON THIN-FT 130DG-UP 1MM 180MM
• Type of Device: BONE PUNCHES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12786960
• MDR Text Key: 280585343
• Report Number: 2916714-2021-00219
• Device Sequence Number: 1
• Product Code: LRY
• UDI-Device Identifier: 04038653211203
• UDI-Public: 4038653211203
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021,03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF771R
• Device Catalogue Number: FF771R
• Device Lot Number: 52359867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2021
• Distributor Facility Aware Date: 10/13/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention