MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 04.268.000S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2020; however exact date of postoperative fracture displacement is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

It was reported that on (b)(6) 2020, a patient underwent the femoral neck system (fns) explanation procedure as femoral neck collapsed requiring conversion to bi-polar hip.The patient was reported to fallen on a few times.The implant was taken out successfully, with no issues or delay, and subsequent revision surgery was completed successfully.There were two locking screws removed as well.Patient status is reported as successfully converted to bipolar hip.This report is for one (1) femoral neck system plate 2 hole - sterile.This is report 1 of 5 for complaint (b)(4).

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.H3, h4, h6- 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 history lot the batch number 56p8717 correspond to the non sterile component art# 60123892.Part: 60123892, lot:56p8717, manufacturing site: grenchen, release to warehouse date: 08 june 2020.A manufacturing record evaluation was performed for the part: 60123892, lot: 56p8717, and no non-conformances were identified.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.

• Brand Name: FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11100722
• MDR Text Key: 224547487
• Report Number: 2939274-2020-05797
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982274458
• UDI-Public: (01)10886982274458
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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
• Device Operator: Health Professional
• Device Model Number: 04.268.000S
• Device Catalogue Number: 04.268.000S
• Device Lot Number: 56P8717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 01/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR