MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; PLATE, BONE

Catalog Number 400.834

Device Problem Failure to Cut (2587)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2020, the screw tip was found blunt and unusable.The screw was discarded and another screw was used to complete the procedure.Procedure was successfully completed without any surgical delay.There was no patient consequences reported.This report is for one (1) ti low profile neuro screw self-drilling 4mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: product was not returned and therefore, no further investigation is possible.Reviewing the received picture, it is visible that the tip of the screw is flattened/missing.Therefore, the complaint condition that the tip was found blunt can be confirmed.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10960100
• MDR Text Key: 220239103
• Report Number: 8030965-2020-09459
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819753457
• UDI-Public: (01)07611819753457
• Combination Product (y/n): N
• PMA/PMN Number: K022012
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.834
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Patient Sequence Number: 1