MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.034.340S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	10/24/2020
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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 9mm titanium cannulated nail-ex with proximal bend 300mm sterile was occurred after inserted the nail and locked it up, they went to remove the nail and not able to nail it since it was in a normal pressure from the knee of cross threading.They were able to remove the insertion handle except removing the nail entirely and was realize that the nail itself was broken right up the notch, we have to reamed up and upsize the nail and implanted 10 x 300mm.There was a surgical delay added about forty (40) minutes to the surgical time since they had to remove and reinsert tibial nail.There were no fragments generated but the removal of the broken, damaged device or fragments had some difficulty.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown insertion instruments: trauma (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 9mm ti cann tibial nail-ex w/prox bend 300mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-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: 10868881
• Report Number: 2939274-2020-05232
• Device Sequence Number: 14440384
• Product Code: JDS
• UDI-Device Identifier: 10886982095084
• UDI-Public: (01)10886982095084
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.034.340S
• Device Catalogue Number: 04.034.340S
• Device Lot Number: H877843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2020
• Initial Report FDA Received Date: 11/19/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR