MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.449S
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
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history lot - part # 04.034.449s, synthes lot # h813549, supplier lot # na, expiration date: 31 dec 2027, release to warehouse date: 21 jan 2019.Manufactured by synthes monument.No ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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, patient underwent a revision of a tibial shaft fracture hypertrophic non-union.The hardware was removed without complications and revised.All implants were intact upon removal nothing was broken.Procedure was completed successfully.Patient was doing fine post-operativlely.There were no comorbidities for the patient.The original date of surgery was on the month of (b)(6) 2019.This report is for one (1) 10mm ti cann tibial nail-ex w/prox bend 345mm-sterile.This is report 5 of 6 for complaint (b)(4).

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12116488
• Report Number: 2939274-2021-03401
• Device Sequence Number: 4423764
• Product Code: JDS
• UDI-Device Identifier: 10886982095244
• UDI-Public: (01)10886982095244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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: 04.034.449S
• Device Catalogue Number: 04.034.449S
• Device Lot Number: H813549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79