MAUDE Adverse Event Report: SYNTHES GMBH 2.1MM TI MATRIX SCREW SELF-TAPPING/4MM; PLATE, BONE

Model Number 04.511.234.01

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/21/2022

Event Type  malfunction  

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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a synthes employee.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 canada reports an event as follows: it was reported that on (b)(6) 2022, the surgeons were implanting matrix orthognathic 1.85mm screws into bone of poor quality.The screws could not be properly tightened, and kept spinning in the bone without gaining purchase.The same situation occurred with 1.85mm self-drilling, self-tapping, and 2.1mm emergency screws.After 10 minutes of delay, the surgeon decided to use another system to complete the procedure.This report is for a 2.1mm ti matrix screw self-tapping/4mm.This is report 2 of 5 for (b)(4).

• Brand Name: 2.1MM TI MATRIX SCREW SELF-TAPPING/4MM
• Type of Device: PLATE, BONE
• 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 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15051593
• MDR Text Key: 302855247
• Report Number: 8030965-2022-04956
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587023670
• UDI-Public: (01)10887587023670
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 04.511.234.01
• Device Catalogue Number: 04.511.234.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• 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-DRILL L4 TAN 1U.; MATRIX SCREW Ø1.85 SELF-TAP L4 TAN 1U.