MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for two (2) unknown 1.7mm cables/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Implanted in 2014, exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 a patient had an existing total shoulder that had sustained a periprosthetic fracture in 2014 that was treated with lc-dcp plate and 1.7mm cables.The patient had a distal humerus fracture unrelated to existing hardware.The patient underwent a total elbow on (b)(6) 2019 and implanted with a 3.5 locking compression plate (lcp) 10 hole and kinamed cables to span the total shoulder and total elbow prosthesis.During the procedure, the two (2) 1.7mm cables were removed to allow room for plate to sit on bone.Concomitant device reported: unk - plate: trauma (part # unknown, lot # unknown, quantity 1).This report is for two (2) unknown 1.7mm cables.This is report 1 of 1 for complaint (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.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error, a design and clinical risk management (dcrm) review will not be completed as it is outside of the scope of the dcrm.There is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during the course of this investigation.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.

• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8388426
• MDR Text Key: 137788153
• Report Number: 2939274-2019-56789
• Device Sequence Number: 1
• Product Code: LRN
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention