MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM; BONE PLATE

Model Number 04.503.223.01

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes 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 on an unknown date, during inspection a package with an order number 56997405, that was received had one (1) screw removed from the packaging.It lost somewhere in shipment.The package got smashed along the way and the screw got smashed out of it.There was no patient involvement.This report is for one (1) ti matrixmidface screw self-drilling 3mm.This is report 1 of 1 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.A device history record (dhr) review was conducted: manufacturing location: (b)(4), manufacturing date: 19-feb-2019, part number: 04.503.223.01, ti matrixmidface screw self- drilling 3mm, lot number: h838311 (non-sterile), lot quantity: 119.Work order traveler met all inspection acceptance criteria.Packaging label log (pll) lppf rev b, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿smashed package and screws lost somewhere in shipment¿ does not indicate breakage.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.The package was not returned and instead the investigation will be done based on the supplied image(s) from the attachments (2 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image(s) was reviewed and the complaint condition for missing screws could not be confirmed.The pictures do not show any screws, so the missing screws cannot be confirmed.However, there is damage to the package as a hole can be seen from the images.As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the package was subjected to rough handling or unintended forces during packaging distribution.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8762637
• MDR Text Key: 150145478
• Report Number: 2939274-2019-59034
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587019086
• UDI-Public: (01)10887587019086
• Combination Product (y/n): N
• PMA/PMN Number: K050608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.223.01
• Device Catalogue Number: 04.503.223.01
• Device Lot Number: H838311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Patient Sequence Number: 1