MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; SCREW, FIXATION, BONE

Model Number 202.874

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales consultant.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.

Event Description

It was reported that on an unknown date, a unknown brand new package that was opened does not have a cortex screw in it.There was no patient involvement.This complaint involves one (1) device.This report is 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.H3, h6: manufacturing location: monument; manufacturing date: september 28, 2009; part: 202.874; 2.7mm cortex screw slf-tpng with t8 stardrive recess 14mm; lot: 6231877; lot quantity: 179.Work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria apart from a non-relevant discrepancy.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found 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.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.

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8174225
• MDR Text Key: 130768655
• Report Number: 2939274-2018-55443
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982145062
• UDI-Public: (01)10886982145062
• Combination Product (y/n): N
• PMA/PMN Number: K113364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 202.874
• Device Catalogue Number: 202.874
• Device Lot Number: 6231877
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Patient Sequence Number: 1