MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - DRILL BITS: TRAUMA

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown drill bit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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, the field return package item variable angle locking screw has a bone clearly a used product as shipped as a new item.It contains threads of the screw there¿s a bone in the screw.He also witnessed some products that were sent back as a replacement to the hospital facility wherein the device such as the drill bit had a dry blood from the label.It was unknown when the issue was discovered.There was no patient involvement.This report is for one (1) drill bits: trauma 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.H11 (corrected data): b1 (adverse event or product problem), b5 (event), h1: the initial complaint was reviewed and found not to be reportable.This mw will be retracted since this report is a duplicate.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: UNK - DRILL BITS: TRAUMA
• Type of Device: DRILL BIT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9029078
• MDR Text Key: 158164972
• Report Number: 2939274-2019-60517
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Patient Sequence Number: 1