MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SELF-TAPPING 16MM; SCREW, FIXATION, BONE

Model Number 200.816

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2019, there was a shipping shortage of one (1) 16mm mini fragment screw.Customer received the empty package with nothing in it.There was no patient involvement.This report is for one (1) 1.5mm cortex screw self-tapping 16mm.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.Manufacturing location: monument, manufacturing date: 27-sep-2018, part number: 200.816, 1.5mm cortex screw self-tapping 16mm, lot number: h745543 (non-sterile).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.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: 1.5MM CORTEX SCREW SELF-TAPPING 16MM
• 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: 8286783
• MDR Text Key: 134462031
• Report Number: 2939274-2019-56122
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982141552
• UDI-Public: (01)10886982141552
• Combination Product (y/n): N
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200.816
• Device Catalogue Number: 200.816
• Device Lot Number: H745543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Patient Sequence Number: 1