MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.026

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number, the device history records review could not be completed.Product was not returned.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 (b)(6) 2020, while putting together the two (2) screw inserters, and two (2) helical blade/screw coupling screws, they wouldn¿t work correctly.It was unknown when the issue was discovered.Patient and procedure involvement are unknown.This report is for one (1) helical blade/screw coupling screw.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: no device is returning for investigation.The customer retaining the product.H6: codes updated.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: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10801052
• MDR Text Key: 215071916
• Report Number: 2939274-2020-04991
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: 10886982070425
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.026
• Device Catalogue Number: 03.037.026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1