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

Model Number	SW790T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem 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.
Additional 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
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10548002
• Report Number: 9610612-2020-00524
• Device Sequence Number: 16892174
• Product Code: MNI
• UDI-Device Identifier: 04038653455256
• UDI-Public: 4038653455256
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K032219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1