MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 TI LCKNG SCR T25 SD 32 FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.005.422
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem 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) 4.0 ti lckng scr t25 sd 32 for im nails.This report is 3 of 3 for (b)(4).
Additional Manufacturer Narrative
(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.

• Brand Name: 4.0 TI LCKNG SCR T25 SD 32 FOR IM NAILS
• Common Device Name: 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: 13176759
• Report Number: 2939274-2022-00036
• Device Sequence Number: 4857127
• Product Code: HSB
• UDI-Device Identifier: 10886982085344
• UDI-Public: (01)10886982085344
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5MM DRILL BIT/QC/GOLD/110MM; 4.0 TI LCKNG SCR T25 SD 32 FOR IM NAILS; 8.5 TI MULTILOC HUM NL LFT/CANN/270-S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male