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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG KAIRISON SHAFT DET.UP 235MM 2MM BONE PUNCHES, RONGEURS
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AESCULAP AG KAIRISON SHAFT DET.UP 235MM 2MM BONE PUNCHES, RONGEURS Back to Search Results
Model Number FK882R
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with fk882r - kairison shaft det. Up 235mm 2mm. According to the complaint description, intrapoerative ends don't meet. There was no described patient harm. Additional information was not provided nor available / was not available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameKAIRISON SHAFT DET.UP 235MM 2MM
Type of DeviceBONE PUNCHES, RONGEURS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key11618856
MDR Text Key266743927
Report Number9610612-2021-00265
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
PMA/PMN Number
K062413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFK882R
Device Catalogue NumberFK882R
Device Lot Number4511875809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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