MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.455S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: 15-nov-2019.Expiration date: 31-oct-2028.Part number: 04.034.455s, 10mm ti cann tibial nail - ex w/prox bend 375mm ¿ sterile.Lot number: 25p6122 (sterile).Lot quantity: 6.Production order traveler met all inspection acceptance criteria.This lot met all dimensional, visual, sterility, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to non-union¿ does not indicate breakage of the nail.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 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) 2020, the patient underwent tibial revision surgery due to non-union.Surgeon explanted the titanium cannulated tibial nail and put in a new nail, and added a small fragment plate and screws, and harvested bone graft using ria.The procedure successfully completed.The patient outcome is unknown.This report is for one (1) 10mm ti cann tibial nail-ex w/prox bend 375mm-sterile.This is report 1 of 7 for (b)(4).

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-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: 10813124
• Report Number: 2939274-2020-05039
• Device Sequence Number: 3525995
• Product Code: JDS
• UDI-Device Identifier: 10886982095268
• UDI-Public: (01)10886982095268
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 04.034.455S
• Device Catalogue Number: 04.034.455S
• Device Lot Number: 25P6122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention