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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP INC DECKER RONGEURS 2X6MM STR 152MM BONE PUNCHES, RONGEURS

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AESCULAP INC DECKER RONGEURS 2X6MM STR 152MM BONE PUNCHES, RONGEURS Back to Search Results
Model Number MF055R
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 04/02/2021
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 to aesculap inc. That a decker rongeurs 2x6mm str 152mm (part # mf055r) was used during lumbar discectomy and foraminotomy procedure performed on (b)(6) 2021. According to the complaint description, the surgeon was using the instrument during the case and the tip broke off and was retained in the patient. There was a 30 min delay in the surgery. Further information was received on apr 13, 2021. Additional intervention was required, longer procedure time and x-ray time for the surgeon to try and recover the broken piece. The broken piece is still in the patient. The patient outcome is unknown. The complaint device was returned to manufacture for evaluation. The adverse event is filed under aag reference (b)(4).
 
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Brand NameDECKER RONGEURS 2X6MM STR 152MM
Type of DeviceBONE PUNCHES, RONGEURS
Manufacturer (Section D)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer (Section G)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
MDR Report Key11739702
MDR Text Key252011757
Report Number2916714-2021-00063
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMF055R
Device Catalogue NumberMF055R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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