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

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2019, the patient had a nonunion on the distal tibia with a medial distal tibia plate.A total of five distal screws were broken, four (4) unknown 2.7 mm va locking screws and one (1) 3.5 mm cortical screw.Two screw fragments were left in the bone.Patient was treated for the nonunion today with antibiotic beads and will comeback for a follow up surgery at a later date.It was unknown if there was surgical delay.Procedure and patient outcome was unknown.This complaint involves six (6) devices.This is 3 of 6 for report (b)(4).This report is for an unknown locking screw.

Event Description

Update: this report is for one (1) unknown - screw locking.

Manufacturer Narrative

Product complaint # (b)(4).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.Additional codes provided for reporting.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: LOCKING
• 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: 9240954
• MDR Text Key: 173910538
• Report Number: 2939274-2019-61765
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention