MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFN; ROD, FIXATION, INTRAMEDULLARY

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - nails: tfn/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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

It was reported that on (b)(6) 2020, an unknown trochanteric fixation nail broke.The tfna revision due to a non-union, possible issue with the nail breaking.The unknown tfn nail was removed yesterday, and a new nail was put in.The procedure successfully completed.The patient outcome is unknown.Concomitant device reported: unk-helical blades (part# unknown; lot# unknown; quantity: 1).Unk-screws (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) unk - nails: tfn.This is report 1 of 1 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.H10 additional narrative: h3, h4, h6: the complaint product is not available to return for investigation.The customer retaining the product.H6: patient code 3191 used to capture additional medical/surgical intervention required.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.

Manufacturer Narrative

Product complaint # (b)(4).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: d11: concomitant product added to complaint.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: UNK - NAILS: TFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10634742
• MDR Text Key: 209984912
• Report Number: 2939274-2020-04505
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE.; UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE.; UNK - NAILS: TFN.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 87