MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SCREW TAP F/D4.5MM; NSTRUMENTS POSTERIOR STABILISATION

Model Number SZ254R

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

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 ennovate screw tap.According to the complaint description the instrument broke after removing.During surgery the device was used inserting the screw.The instrument broke when removed from the vertebra.The broken piece remained in situ.There has been no damage to patient.There is no risk of further damage to patient.There is no chance that broken piece will travel from vertebra body and could damage patient.Patient is feeling great and will soon leave hospital.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the instrument arrived with a broken off tip which was not enclosed.The fracture surface of the device shows typical signs of a multi axial stress condition of bending and torsion.A review of the device quality and manufacturing history records was not possible because of the unknown batch of the device.Due to the circumstances that the fracture surface of the device shows typical signs of a breaking caused by mechanical overstress we assume that the failure is most probably usage related.Therefore a material or manufacturing error can be excluded.

• Brand Name: ENNOVATE SCREW TAP F/D4.5MM
• Type of Device: NSTRUMENTS POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10326290
• MDR Text Key: 202382526
• Report Number: 9610612-2020-00330
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SZ254R
• Device Catalogue Number: SZ254R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1