MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM GUIDE WIRE WITH FLUTES 450MM; PIN, FIXATION, SMOOTH

Model Number 02.207.001

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 during a slipped capital femoral epiphysis (scfe) procedure on an unknown date, the surgeon encountered an issue with the drill bit where it was binding and pushing on the guide wire along with the drill bit.The left hip was done first.The surgeon reported that the guidewire pushed the femoral head and into the acetabular area; although, it was not sure if the acetabulum was completely penetrated.It was mentioned that the same drill bit was problematic on the contra lateral side; the surgeon had to be extra careful to ensure that the same issue would not occur.It was noted that during the procedure four (4) guide wires bent; however only one of the wires penetrated the acetabulum on the right hip.The procedure was successfully completed despite the drill bit issue.There was a thirty to forty-five (30-45) minute surgical delay reported.Concomitant device reported: scfe screw (part 02.207.626, lot unknown, quantity 1), scfe screw (part 02.207.625, lot unknown, quantity 1), oval washer (part 02.207.637, lot unknown, quantity 1).This report is for a guide wire.This is report 5 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.A product investigation was completed: the implant(s) was not returned, and the investigation was completed based on the supplied image.The image was reviewed and the complaint condition for bent could not be confirmed as the image showed five guide wires and two were bent and the other three appear to be straight.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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.

• Brand Name: 2.8MM GUIDE WIRE WITH FLUTES 450MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8944891
• MDR Text Key: 198904999
• Report Number: 2939274-2019-60197
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886982051721
• UDI-Public: (01)10886982051721
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.207.001
• Device Catalogue Number: 02.207.001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Patient Sequence Number: 1
• Treatment: SCFE SCR Ø7.3 CANN L80/20; SCFE SCR Ø7.3 CANN L85/20; WASHER Ø18 OVAL T2 F/SCFE SCREW
• Patient Weight: 100