MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.005.420

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

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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 on (b)(6) 2020, the patient underwent a revision procedure and removal of the multi lock femoral nail.The implant removal was due to the quality of implants and non-union.Initially, patient had a zimmer biomet proximal humerus plate that was revised to synthes multiloc humeral nail due to zimmer plate failure.It was also mentioned that the patient had an infection prior to surgical implant that ultimately led to the non-union.During the procedure, the femoral implant was removed ahead proximal nail to get the proximal screw still intact.The patient was then revised to a reverse shoulder.The procedure was successfully completed.It is unknown if there was a surgical delay.Patient status is unknown.This report is for one (1) 4.0mm ti locking screw w/t25 stardrive 30mm for im nails.This is report 4 of 8 for (b)(4).

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10816753
• MDR Text Key: 215536705
• Report Number: 2939274-2020-05056
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982085320
• UDI-Public: (01)10886982085320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.005.420
• Device Catalogue Number: 04.005.420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 3.5MM TI LCKNG SCR SLF-TPNG W/ STRDR RCES 42MM; 3.5MM TI LCKNG SCR SLF-TPNG W/ STRDRV RCES 40MM; 4.0MM TI LCKNG SCRW W/T25 STDRV 66MM FR IM NALS; 4.0MM TI LCKNG SCRW W/T25 STDRV 66MM FR IM NALS; 4.0MM TI LCKNG SCRW W/T25 STRDRV 26MM FR IM NALS; 4.0MM TI LCKNG SCRW W/T25 STRDRV 66MM FR IM NALS; 8.5MM TI MLTC HMRL NAL LFT/CANN/225MM-STRLE
• Patient Outcome(s): Required Intervention