MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCR Ø1.5 SELF-DRILL L4 TAN; PLATE, BONE

Catalog Number 04.503.224.01

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional product code: dzl.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: monument manufacturing date: 01-mar-2022 part number: 04.503.224.04c, ti matrixmidface screw self- drilling 4mm lot number: 695p145 (non-sterile) lot quantity: 120 production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and determined to be conforming.A total of 123 labels were printed.120 labels were placed on product; 1 label was placed on the pll and 2 labels were destroyed.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 ¿no screw in sealed package¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 synthes reports an event in canada as follows: it was reported on an unknown date that matrix midface package was shipped but no screw was in package, package was sealed.It is unknown if the event occurred during sterile processing, field inspection or during internal service activities such as calibration.There was no patient outcome / consequences.This report is for one (1) scr ø1.5 self-drill l4 tan this is report 1 of 1 for complaint (b)(4).

• Brand Name: SCR Ø1.5 SELF-DRILL L4 TAN
• Type of Device: PLATE, BONE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380
• MDR Report Key: 14756643
• MDR Text Key: 297993159
• Report Number: 2939274-2022-02310
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819908505
• UDI-Public: (01)07611819908505
• 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,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 Catalogue Number: 04.503.224.01
• Device Lot Number: 695P145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1