MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year is 2021; however exact date of post-operative infection development is unknown.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.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 or Problem Description
It was reported that on (b)(6) 2021, a patient underwent a procedure to treat the distal tibia and fibula fracture with a tibia nail and fibula plate.The patient had zero healing properties and consequently, the patients distal leg was quite rotting off.On (b)(6) 2021 the tibia nail along with five (5) 5.0mm locking screws were removed and patient's leg was amputated below the knee.Clinical outcome experienced by the patient was infection.No further information provided.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 40mm for im nails.This is report 6 of 7 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS
• Common Device Name: SCREW, FIXATION, BONE
• 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: 12779356
• Report Number: 2939274-2021-06556
• Device Sequence Number: 6025318
• Product Code: HWC
• UDI-Device Identifier: 10886982085986
• UDI-Public: (01)10886982085986
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.530
• Device Catalogue Number: 04.005.530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/09/2021
• 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: 12 TI CANN TIB NAIL-EX PROX BEND 375-S; 3.5 VA P TIB S BEND/8H/147/LT; 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 46 FOR IM NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male