MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; NAIL, FIXATION, BONE

Catalog Number UNK - NAIL HEAD ELEMENTS: FNS

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

Patient Problems Failure of Implant (1924); No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown - nail head elements: fns bolt/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a synthes rep.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent the removal of an unknown femoral neck system implant due to unknown reasons on (b)(6) 2020.Patient had osteopenic bone, which lead to implant failure.Patient received a revision hip.The initial surgery was on (b)(6) 2020.The procedure outcome is unknown however, the patient is doing well.This complaint involves unknown number of devices.This report is for one (1) unk - nail head elements: fns anti-rotation.This report is 3 of 3 for (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.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

Device report from synthes reports an event in united states.

• Brand Name: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9875130
• MDR Text Key: 186113505
• Report Number: 2939274-2020-01502
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - NAIL HEAD ELEMENTS: FNS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention