MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; AWL

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown awl.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown awl.Pma/510(k) number is not available.Product was not returned.Device history records review could not be completed without lot number.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.Reported under maude mw5082249: 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.[(b)(4); mw5082249].

Event Description

This report is against user facility medwatch number mw5082249.The only information contained in this report is correction or additional information.

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.The initial complaint was reviewed and found not reportable.Additional information was received from the reporter indicating the device is not a synthes device.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

The initial complaint was reviewed and found not reportable.Additional information was received from the reporter indicating the device is not a synthes device.

• Type of Device: AWL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8302360
• MDR Text Key: 135011510
• Report Number: 2939274-2019-56299
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Patient Sequence Number: 1