MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 THRD CERCLAGE POSITIONING PIN-SILE; CERCLAGE FIXATION

Model Number	298.803S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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, the patient underwent for a revision surgery.During the surgery, the hardware was removed from the patient's femur and used ria to get bone graft from operative femur due to a nonunion from the previous surgery.Surgeon revised femur using a universal femoral nail, and a va condylar plate.He then put in bone graft collected from ria in the nonunion site.The procedure was successfully completed.The patient's surgery was revised.This complaint involves fourteen (14) devices.This report is for (1) 4.5 thrd cerclage positioning pin-sile.This report is 8 of 14 for (b)(4).

• Brand Name: 4.5 THRD CERCLAGE POSITIONING PIN-SILE
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12515808
• Report Number: 2939274-2021-05705
• Device Sequence Number: 14296729
• Product Code: JDQ
• UDI-Device Identifier: 10886982182531
• UDI-Public: (01)10886982182531
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K992891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 298.803S
• Device Catalogue Number: 298.803S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.7MM CABLE WITH CRIMP 750MM-STERILE; 1.7MM CABLE WITH CRIMP 750MM-STERILE; 4.5 THRD CERCLAGE POSITIONING PIN-SILE; 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 5.0 MM CANNULATED CONICAL; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING
• Outcome Attributed to Adverse Event: Required Intervention