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 Problems Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) 2020, a helical blade/screw coupling screw had an issue during surgery.During insertion of the lag screw the coupling screw would disengage and unwind, the surgeon repeatedly had to retighten the connection screw in order to advance the lag screw which he had difficulty inserting as the patient had hard/dense bone and the surgeon did not tap for the lag screw.Upon post-op images being taken it was noticed that there were two small metal fragments in the patient soft tissue which appear to be some of the threads from the coupling screw.There was no surgical delay reported.The surgery was completed successfully.The patient outcome was successful.This report is for one (1) helical blade/screw coupling 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.H10 additional narrative: h3, h4, h6: 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.Product complaint # (b)(4).Investigation summary = product was not returned.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.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: 10941694
• MDR Text Key: 219493110
• Report Number: 2939274-2020-05431
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)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,health
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• 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: 12/23/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEM: TFN LAG SCREW
• Patient Outcome(s): Required Intervention