MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.85MM TI MATRIX SCREW SELF-TAPPING/4MM; PLATE, BONE

Model Number 04.511.204.01

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that, the titanium matrix screw self tapping was removed from the patient and the self retaining would not engage in the screw.Procedure was completed successfully with fifteen (15) minutes surgical delay and no patient consequences.Concomitant devices reported: unknown matrixorthognathic plate (part# unknown, lot# unknown, quantity 1), unknown screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) 1.85mm ti matrix screw self-tapping/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.A manufacturing record evaluation could not be performed as the lot number could not be determined from the available information.Also could not find any markings on the part.Visual inspection: the 1.85mm ti matrix screw self-tapping/4mm was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the thread of the self-retaining screw is found stripped near proximal side of screw.The compliant condition of screw not able to self-retained may be confirmed due to threads of the screw being stripped.No other issues were identified with the returned device.Functional test: the functional test cannot be performed on the self-retaining screw as only the screw was returned and could not replicate the use of device through laboratory analysis.Dimensional inspection: the dimensional inspection could not be performed due to post manufacturing damage.Document/specification review: due to lot code being unknown, the date of manufacture cannot be confirmed and only the current revision of drawings were reviewed.Investigation conclusion the complaint condition was confirmed for the 1.85mm ti matrix screw self-tapping/4mm.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11806724
• MDR Text Key: 251527694
• Report Number: 2939274-2021-02305
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587023410
• UDI-Public: (01)10887587023410
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 04.511.204.01
• Device Catalogue Number: 04.511.204.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/11/2021
• Patient Sequence Number: 1
• Treatment: MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76; UNK - PLATES: MATRIXORTHOGNATHIC