MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.446S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Only event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4), manufacturing date: may 18, 2019, expiration date: april 30, 2028, part number: 04.034.446s, 10mm ti cann tibial nail - ex w/prox bend 330mm ¿ sterile, lot number: 3l25957 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Packaging label log (pll) lppf, lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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 infection¿ 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.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.(b)(4).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, a removal surgery of tibial nail was performed due to infection and placement of antibiotic beads.Original implantation surgery was performed on (b)(6) 2020.Surgical procedure outcome and patient status is good.Concomitant devices reported: screws: locking (part number unknown, lot unknown, quantity 5); end caps: tibial nail (part number unknown, lot unknown, quantity 1).This report involves one (1)10mm ti cann tibial nail-ex w/prox bend 330mm-sterile.This is report 1 of 7 for (b)(4).

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-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: 11154150
• Report Number: 2939274-2021-00173
• Device Sequence Number: 4106986
• Product Code: JDS
• UDI-Device Identifier: 10886982095237
• UDI-Public: (01)10886982095237
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 04.034.446S
• Device Catalogue Number: 04.034.446S
• Device Lot Number: 3L25957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS: TIBIAL NAIL; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention