MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 340MM / RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

Model Number 04.033.064S

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device history lot: part number: 04. 033. 064s, synthes lot number: l945713, manufacturing site: (b)(4), release to warehouse date: july 05, 2018, expiry date: april 30, 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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) 2020, during a femoral recon nailing of 1/3 shaft fractured femur on the patient, the right titanium cannulated femoral recon nail was becoming incarcerated within the femoral shaft. The surgeon had to reamed up to 12mm for the insertion of the 10mm nail. Upon removal of the incarcerated nail, there was femoral neck fracture. After the removal of the 10mm nail, a 9mm nail was inserted, and the femoral neck fracture was reduced and fixated with 6. 5 cannulated screws. The surgeon had to ream to 14. 5mm in order to insert the 9mm nail. The surgeon complaint that the proximal portion of the nail was too wide in diameter, therefore resulting in the incarnation due to the long or wide proximal taper of the femoral recon nail. The medical intervention required since, they had to change tables to insert 6. 5 cannulated screws into the femoral neck after the insertion of the 9mm nail and extra x-rays were needed. There was a surgical delay approximately of one hour and sixty (60) minutes. Procedure successfully completed. Patient status is good. Concomitant devices reported: unknown reamer (part # unknown, lot # unknown, quantity # 1). This complaint involves one (1) device. This is report 1 of 1 for (b)(4).

• Brand Name: 10MM / TI CANN FRN / GT 340MM / RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10002256
• MDR Text Key: 189898946
• Report Number: 2939274-2020-02052
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.033.064S
• Device Catalogue Number: 04.033.064S
• Device Lot Number: L945713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/27/2020 Patient Sequence Number: 1