MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM; BONE PLATE

Model Number 04.511.206.01

Device Problems Failure to Advance (2524); Failure to Cut (2587); Difficult to Advance (2920)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unknown.Lot number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Reporter email address is unknown.Reporter is a synthes sales consultant.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during a procedure on (b)(6) 2018, the titanium (ti) matrix screw self-tapping would not engage into the pre-drilled hole.A matrix drill bit j-latch was used to put in the screw.It is unknown if it was an issue with the screw or the drill bit.Another unknown drill bit and unknown screw were used, and they worked fine.It is unknown if there was surgical delay or what the patient outcome was.This report is for a 1.85mm ti matrix screw self-tapping/6mm.This is report 1 of 2 for (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.Flow: device interaction/functional visual inspection: the screw was received at us cq with no visual defects.There are slight signs of use in the drive recess in the form of scratches.This is not consistent with the reported complaint condition, thus the complaint is unconfirmed.Functional test a functional test could not be completed as the event occurred intra-operatively and could not be recreated.Dimensional inspection dimensional analysis was performed, the major thread diameter measured 1.81mm (caliper ca215p), which is below the specification of 1.85 mm max.Document/specification review the following drawing(s) was reviewed; 1.85 mm orthognathic self-tapping screw device history record (dhr) review could not be completed as the lot number is unknown.Conclusion: the complaint condition is unconfirmed as the screw was received with no defects.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is likely that the complaint was caused by other devices involve in the complaint.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.

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: h11: corrected data: b5 was updated.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 further reported that there may have been a new hole created in the bone, however, it was not confirmed.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Sending follow up report 2 per fda request as previous follow up reports went from 1 to 3.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/6MM
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7813511
• MDR Text Key: 118249848
• Report Number: 2939274-2018-53454
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587023458
• UDI-Public: (01)10887587023458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.511.206.01
• Device Catalogue Number: 04.511.206.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male