MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Model Number 03.010.441

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.The investigation summary: the investigation could not be completed; no conclusion could be drawn.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.

Event Description

It was reported that during a procedure on an unknown date, the drill bit was missing nails attached to a suprapatellar insertion handle.The unknown screw and drill bit was successfully inserted into the nail.No further incident but the initial part of the drill bit did not goes to the nail.It is unknown if there was a surgical delay.Patient and procedure outcome is unknown.Concomitant devices reported: unknown insertion handle (part # unknown, lot # unknown, quantity 1), unknown screw (part # unknown, lot # unknown, quantity 1), unknown nail (part # unknown, lot # unknown, quantity unknown).This complaint involves three (3) device.This report is 3 of 3 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.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 during a procedure on (b)(6) 2018, while drilling through the aiming arm using the supra patellar insertion handle, the calibrated three-fluted drill bit missed the static transverse hole in the titanium cannulated tibial nail.It was meant to match up with the applied physical deformation to the insertion handle/aiming arm construct in order to achieve correct alignment which allowed the drill bit to pass through the nail as desired.It was further noted that the whole construct: insertion handle, aiming guide, and drill sleeves allow for enough play that certain patients' bone/tissue deform the construct enough to create misalignment.Following this, the titanium locking screw was inserted as intended without further incident.No further incident but the initial part of the drill bit did not go to the nail.It is unknown if there was a surgical delay.Patient and procedure outcome is unknown.Concomitant devices: titanium locking screw (part: 04.005.428s, lot: unknown, quantity: 1), titanium cannulated tibial nail (part: 04.034.349s, lot: unknown, quantity:1) this report is for one (1) aiming arm.This is report 3 of 3 for (b)(4).

• Brand Name: AIMING ARM FOR SUPRAPATELLAR
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7992753
• MDR Text Key: 124679014
• Report Number: 2939274-2018-54530
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: (01)10886982068835
• Combination Product (y/n): N
• PMA/PMN Number: K111667
• 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: 10/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.441
• Device Catalogue Number: 03.010.441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1