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

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.

• 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 Key: 16271665
• MDR Text Key: 308531065
• Report Number: 9610612-2023-00016
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: SZ254R
• Device Catalogue Number: SZ254R
• Device Lot Number: 52409385
• 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 Received: 01/31/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/20/2023
• 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 Number: 1
• Patient Outcome(s): Required Intervention