MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW,FIXATION,BONE

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

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient date of birth/age, and weight was not provided for reporting.Date of event is unknown.This report is for two (2) unknown screws.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for two (2) unknown screws.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 patient had original surgery approximately 5-7 years ago for a tibial fracture.Patient was implanted with one (1) 10mm/345mm titanium tibial nail and two (2) 24mm/ 4.9mm titanium locking bolts.One bolt was implanted proximally and the other bolt implanted distally.On an unknown date post-operatively, patient presented with knee and patella irritation.In preparation for the revision procedure, the sales consultant ordered thru the evaluation department the evaluation set # 105.570 ti tibial nail insertion and removal set.Later the sales consultant was notified by email from the evaluation department this set was discontinued and no longer available.It was suggested the 102.57e solid nail extraction set as the substitute for the nail removal.On (b)(6) 2017, surgeon attempted to remove all implants.During the procedure, the extraction screw for tibial nail instrument that was needed for nail removal, was not included in the solid nail extraction set.This instrument attaches to the proximal end of the nail end cap, along with the inserter and slotted hammer instruments.Without this instrument, the surgeon was unable to remove the tibial nail.During the surgery, and to complete the procedure, the sales consultant left the operating room and traveled to another hospital to obtain their ex instrument set for the nail removal.The ex tibial nail insertion instrument set had the instruments that helped to facilitated the patients nail removal.Due to this event, surgery was extended an additional 90-120 minutes.It was reported that no fragments were generated during implant removal.All implants have been retained by the hospital.Surgery was completed successfully and patient has been reported in stable condition.This report, (b)(4), captures the revision due to patient¿s knee and patella irritation.Missing instrument incident will be captured under (b)(4).This report is for two (2) unknown screws.This is report 3 of 3 for (b)(4).

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7146404
• MDR Text Key: 95773898
• Report Number: 2939274-2017-50436
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention