MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 340MM/RIGHT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.254S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: 30-jul-2020 expiration date: 30-jun-2030 part number: 04.037.254s, 12mm/130 deg ti cann tfna 340mm/right- sterile.Lot number: 64p3591 (sterile).Lot quantity: 5.One piece was scrapped in cell for a chip wrap issue.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in-process / inspect dimensional / final, met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Labels identify nail as 340mm/right.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn was reviewed and determined to be conforming.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 ¿surgeon put a right nail in the left femur¿ does not indicate breakage of the nail or any of its components.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.(b)(4).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) 2021, during a procedure, the surgeon put a right trochanteric femoral nailing advanced (tfna) nail in the left femur.Before nail insertion, the size, length, and side of the nail was called out loud to the room.No one objected.The nail was given to the nurse, who opened the nail and gave it to scrub tech.The scrub tech attached the nail to the jig and gave it to the doctor who inserted the nail.After nail and helical blade were inserted, surgeon went to the knee to do distal interlocks.When surgeon took the first x-ray, it was noticed that the nail perforated the anterior cortex.Surgeon took the right tfna nail out and put the left tfna nail in, then plated the distal femur with a variable angle (va) condylar plate.There was an unspecified amount of surgical delay.The procedure was successfully completed.The patient status is unknown.This report is for one (1) 12mm/130 deg ti cann tfna 340mm/right-sterile this is report 1 of 1 for complaint (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 340MM/RIGHT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11709087
• Report Number: 2939274-2021-02022
• Device Sequence Number: 19806829
• Product Code: HSB
• UDI-Device Identifier: 10886982097347
• UDI-Public: (01)10886982097347
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.254S
• Device Catalogue Number: 04.037.254S
• Device Lot Number: 64P3591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2021
• Initial Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR