MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM; BONE PLATE

Catalog Number 04.503.224.01C

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint cannot be confirmed.A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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 on an unknown date, the patient underwent for a surgery.During the surgery, screwdriver do not hold the implant screws.It was unknown if the surgery completed successfully.There was no patient consequence.This complaint involves seven (7) devices.This report is for (1) ti matrixmidface screw self-drilling 4mm.This report is 2 of 5 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event is unknown.Additional product code: dzl.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 MATRIXMIDFACE SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13056246
• MDR Text Key: 284509701
• Report Number: 8030965-2021-10379
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819908512
• UDI-Public: (01)07611819908512
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP; UNK - SCREWDRIVERS