MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.005.422

Device Problem Device-Device Incompatibility (2919)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).Additional product code: hwc.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 an unknown date, the patient underwent for a surgery.During the surgery, the two (2) titanium locking screw inserted distally created fracture resulting in nail distal penetration of humerus posterior wall.Drill bit was broken during plating portion.The two pieces were both removed.There was 90 minutes surgical delay.The procedure was successfully completed.The patient outcome was unknown.Concomitant devices reported: multiloc humeral nail (part# 04.019.270s, lot# l743741, quantity 1); titanium locking screw (part# 04.005.434, lot# unknown, quantity 2).This complaint involves three (3) devices.This report is for (1) 4.0mm ti locking screw w/t25 stardrive 32mm for im nails.This report is 1 of 3 for (b)(4).

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13176767
• MDR Text Key: 288498460
• Report Number: 2939274-2022-00032
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982085344
• UDI-Public: (01)10886982085344
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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 Model Number: 04.005.422
• Device Catalogue Number: 04.005.422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/06/2022
• 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: 2.5MM DRILL BIT/QC/GOLD/110MM; 4.0 TI LCKNG SCR T25 SD 44 FOR IM NAILS; 8.5 TI MULTILOC HUM NL LFT/CANN/270-S
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male