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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for two (2) unknown cables/wires/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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) 2019, the unknown cable was fed around the patient¿s femur and into the provisional tensioning device as described in the technique guide.The surgeon attempted to lock the cable lock but found it extraordinarily difficult and had to force the lock.When a slight amount of tension was applied to the unknown cable, the unknown cable snapped at the cable lock.The same thing happened when a second unknown cable was used.The surgeon was able to lock and tensioned a third unknown cable but once tensioned, the surgeon could not get the provisional tensioning device hold to lock on the unknown cable.They switched out the cable lock with another cable lock they had in there set but had the exact same performance.The surgeon eventually pulled the tension manually and had the surgeon¿s resident crimp the cable.After the case, the surgeon and an associate attempted to feed a new unknown cable through the tensioner to try and narrow down the problem, but they were unable to get the cable lock or tension holder to lock onto the unknown cable.There was a 15 minutes surgical delay.The procedure and patient outcome is unknown.Concomitant medical products reported: unknown cable/wire trauma: (part #: unknown, lot #: unknown, quantity #: 1).This report is for two (2) unknown cables/wires.This is report 1 of 4 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.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

Update info: it was reported that two (2) cables/wire devices failed in the field, however, when tested after the case they could not make any of the devices function properly.

Event Description

03/12/2019: additional information received that the sales consultant was present during the case on (b)(6) 2019.Alert date should be changed to (b)(6) 2019 to reflect the awareness date.

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 manufacturer narrative.B5; additional information 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.

Event Description

It was noted that two (2) provisional tensioning devices were used during the procedure and an additional two (2) were used after the case.Concomitant device reported: cable/wire trauma: (part/lot unknown, quantity 1); provisional tensioning device (part 391.884, lot p247358, quantity 2).This is report 1 of 5 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.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: 8293601
• MDR Text Key: 134891553
• Report Number: 2939274-2019-56179
• 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,Followup,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 03/08/2019; 03/12/2019
• Supplement Dates FDA Received: 03/07/2019; 03/11/2019; 03/13/2019
• Patient Sequence Number: 1