MAUDE Adverse Event Report: AESCULAP AG S4 SET SCREW NEW VERSION; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number SW790T

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.

Event Description

It was reported that a s4 set screw was being used during a procedure.According to the complainant, the device slipped the thread while being screwed to lock.No patient complications reported as a result of the event.Additional information has been requested, but has not yet been made available.

Manufacturer Narrative

Update: the surgery was delayed about 05 mins; took it out and replaced by other; treatment was fine.Investigation results: we made a visual inspection of the screw.In the first step we investigated the hexagon of the screw.The hexagon of the screw is in a proper condition.In the next step we investigated the bottom of the screw.Here we found no signs of wear or impacts.After that we checked the thread of the screw.The thread is in a proper condition.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.Rationale: the screw shows no defects, wear, impressions or other damages.

• Brand Name: S4 SET SCREW NEW VERSION
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10548002
• MDR Text Key: 207541112
• Report Number: 9610612-2020-00524
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04038653455256
• UDI-Public: 4038653455256
• Combination Product (y/n): N
• PMA/PMN Number: K032219
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW790T
• Device Catalogue Number: SW790T
• Device Lot Number: 52588760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1