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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SCREW TAP F/D4.5MM; SPINE SURGERY

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AESCULAP AG ENNOVATE SCREW TAP F/D4.5MM; SPINE SURGERY Back to Search Results
Model Number SZ254R
Device Problem Expulsion (2933)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2023
Event Type  Injury  
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 sz254r - ennovate screw tap f/d4.5mm.According to the complaint description, the surgeon was using the 4.5mm tap during the fixation at which point the shaft of the tap broke into 3 pieces.The surgeon was able to retrieve 2 pieces from the bone using forceps but then had to drill away the bone to retrieve the third piece.The patient was not harmed as a result of this and so no extra therapy was required.The procedure was an l4/l5 posterior lumbar interbody fusion (plif).An additional medical intervention was necessary.This event prolonged the surgery for 10 minutes.Additional information was not provided.The adverse event is filed under aag reference: (b)(4).
 
Manufacturer Narrative
Additional information/ correction: d4 - lot added.D9 - date returned to the manufacturer.H3 - device evaluation.H4 - production date added.H6 - codes updated.Investigation results: visual investigation: the tap arrived with broken off tip, the broken off pieces were enclosed.During a visual inspection we found the treaded end of the tap bent.In the next step we made a microscopical inspection of the fracture surface.Here we found the typical signs of a multi axial stress condition of bending and torsion.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.There are no similar complaints against the same lot number with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x 1(5) probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the root cause for the breakage of the tap was a overload situation, caused by levering in conjunction with mechanical overload.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably user related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
 
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Brand Name
ENNOVATE SCREW TAP F/D4.5MM
Type of Device
SPINE SURGERY
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 gruen
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key16271665
MDR Text Key308531065
Report Number9610612-2023-00016
Device Sequence Number1
Product Code HWX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2023
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
Device Operator Health Professional
Device Model NumberSZ254R
Device Catalogue NumberSZ254R
Device Lot Number52409385
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2023
Initial Date FDA Received01/31/2023
Supplement Dates Manufacturer Received04/06/2023
Supplement Dates FDA Received04/20/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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