MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 357.133

Device Problems Dull, Blunt (2407); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the threads of two extraction bolts were stripped during a tibia nail exchange procedure on (b)(6) 2017.During a tibia nail exchange the doctor was trying to thread the extraction bolt into the top of the nail.The doctor said the extraction bolt would only thread in part way.When the doctor used the slide hammer to pull the nail out, he only gave it two light blows and the extraction bolt came out of nail.Upon inspection of the extraction bolt it was noticed that part of the threads was stripped and would not allow the extraction bolt to thread further down into the nail.Therefore, the rafn set was opened to get another extraction bolt.The same thing happened with the second extraction bolt as did it with the first.Threads on the second extraction bolt was damaged as well.As a result of these items not working properly the surgery was delayed 2.5 hours due to the fact that the doctor had to find a different way to remove the nail; a winquist #5 (a universal nail extraction set) was used to thread into the nail to pull it out.The surgeon considered putting a plate on.No x-rays were taken during this time.This was revision surgery performed due to non-union (captured under linked complaint (b)(4)).Concomitant devices report: nail (part # unknown, lot # unknown, quantity: 1), slide hammer (part # unknown, lot # unknown, quantity: 1).This report is for one (1) extraction screw for ti femoral and tibial nails.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Product development investigation was completed.The returned screw was examined and the complaint condition was able to be confirmed as the distal threaded tip was found to be deformed.The complaint condition was unable to be replicated due to post-manufacturing damage.The extraction screw for ti femoral and tibial nails (357.133) is a common trauma instrument, noted in 11 nail system technique guides including: titanium cannulated tibial nails, adolescent lateral entry femoral nail, and titanium retrograde/antegrade femoral nail.In each instance the extraction screw is available if implant removal is desired.The extraction screw is threaded into the implanted nail and a hammer guide is attached to the extraction screw allowing for implant removal with light hammer blows.Relevant drawings for the returned device were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number.Device history records review was completed for part# 357.133, lot# 1513641.Manufacturing location: (b)(4), release to warehouse date: jun 23, 2006.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No definitive root cause could be determined; the failure mode is typically associated with attempted off-axis insertion leading to thread deformation.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: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7110722
• MDR Text Key: 94623693
• Report Number: 2939274-2017-50236
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883(10)1513641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: 1513641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR