MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS; SCREW,FIXATION,BONE

Device Problem Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 (b)(6) 2010, the patient underwent an unknown type of fusion surgery which has resulted to increase pain after surgery.The patient was implanted with an unknown device/s.The patient status and outcome are both unknown.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity # 1); unknown plate (part# unknown, lot# unknown, quantity # 1).This report is for one (1) screw.This is report 1 of 2 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.D10: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided.The image was reviewed and the complaint condition could be confirmed.After reviewing the provided x-ray image, it was seen that an unknown screw was broken.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 - SCREWS
• 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: 9627613
• MDR Text Key: 188486418
• Report Number: 2939274-2020-00390
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: SPINE; UNK - PLATES: SPINE; UNK - SCREWS; UNK - SCREWS
• Patient Outcome(s): Required Intervention