MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.224.01C

Device Problem Break (1069)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in south korea as follows: it was reported that all screws broke intraoperatively at the same surgery.No further information provided.This report is for one (1) ti matrixmidface screw self-drilling 4mm.This is report 5 of 6 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.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.H10 additional narrative: b3, b5: the date of event was reported as unknown on the initial report; and has been updated accordingly.It was further reported that the procedure was completed successfully and no broken fragments were left in the patient.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14630380
• MDR Text Key: 301242994
• Report Number: 8030965-2022-03766
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K083388
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.224.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATRIX SCREW Ø1.85 SELF-TAP L4 TAN 1U I/.; MATRIX SCREW Ø1.85 SELF-TAP L6 TAN 1U I/.; SCR Ø1.5 SELF-DRILL L4 TAN 1U I/CLIP.; SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP (QTY 2).