MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; STAPLE, FIXATION, BONE

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown bone staple/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.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 an unknown date, the surgeon used an unknown elite-y implant that broke in use for midfoot fusion in the calcaneocuboid joint.The surgeon also reported a fracture.Surgical outcome is unknown.It was noted that this is the only implant the surgeon used in the unknown procedure.The patient outcome reported is that they have not healed.This report is for one (1) unk - bone staple: elite.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Patient codes: code 1870 (fracture(s)) was inadvertently used for this complaint.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, patient had an isolated midfoot fusion for arthritis in the calcaneal cuboid (cc) joint where an unknown elite y was implanted.On an unknown postoperative date, the elite y implant broke at the shoulder part of the implant.The patient had not yet healed.On an unknown date, patient underwent revision surgery to remove the broken implant.Fragments were generated from the broken device but were easily removed without additional intervention.The removal procedure was successfully completed without surgical delay.Patient¿s condition is monitored, and the surgeon will assess whether revision surgery is necessary in 2019.

• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7966992
• MDR Text Key: 123798106
• Report Number: 2939274-2018-54384
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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: 10/10/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention