MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/125 DEG TI CANN TFNA 360/LEFT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.127S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Without a valid lot number, the dhr is not available.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The investigation could not be completed.No conclusion could be drawn, as no product was received.Investigation summary: 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.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 an unknown date, the patient underwent removal of distal locking screw and trochanteric femoral nailing advanced (tfna) nail due to breakage.The initial citation of the device was one year ago on (b)(6) 2020.(b)(6) of this year, the helical blade was removed, it was also reported that the patient fell and had a neck and locking screw breakage.Trochanteric femoral nailing advanced (tfna) nail which removed as well as broken locking screw, conversion to a total hip arthroplasty following removal of helical blade and subsequent fall which resulted in a displaced femoral neck fracture.Approximately 6 weeks after helical blade was removed, patient fell and suffered a displaced femoral neck fracture which lead to the tfna removal and conversion to a total hip arthroplasty.Patient had three (3) surgeries, implantation of tfna long nail on (b)(6) 2020.Removal of helical blade because of pain at blade site on lateral cortex of femur in (b)(6) 2021.Conversion to a total hip arthroplasty follows a femoral neck fracture.This is when broken distal 5.0mm locking screw was discovered.Broken distal locking screw and nail were removed successfully.This (b)(4) captures the intra-op event removal of distal locking screw and trochanteric femoral nailing advanced (tfna) nail due to breakage while (b)(4) captures the post-op event which involves removal of helical blade due to pain at blade site on lateral cortex of femur in (b)(6) 2021.Concomitant devices reported: unknown nail head elements: tfna helical blade (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) 11/125 deg ti cann tfna 360/left - sile.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d4 h3, h4, h6: part 04.037.127s, lot 12l9032: manufacturing location: monument.Manufacturing date: august 02, 2019.Expiration date: june 30, 2029.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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.H11: corrected data: d10.

• Brand Name: 11/125 DEG TI CANN TFNA 360/LEFT - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11615993
• Report Number: 2939274-2021-01685
• Device Sequence Number: 16985954
• Product Code: HSB
• UDI-Device Identifier: 10886982096418
• UDI-Public: (01)10886982096418
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.127S
• Device Catalogue Number: 04.037.127S
• Device Lot Number: 12L9032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/125 DEG TI CANN TFNA 360MM/LEFT - STERILE; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Age: 88 YR
• Patient Weight: 52