MAUDE Adverse Event Report: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Migration (4003)

Patient Problems Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - nail head elements: helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in (b)(6) as follows: 3 tfna cases with spiral blade.Patient: 2/3.It was reported that, during the post-op trochanteric stem procedure there was a migration of the spiral blade, even after tightening the tab until the end.Also loss of reduction was noted after pre-discharge x-ray.Concomitant device reported: concomitant device reported: unk - nails: tfna (part # unknown; lot # unknown; quantity: 1), unk - screws: nail distal locking (part # unknown; lot # unknown; quantity: unknown), unk - rods: trauma (part # unknown; lot # unknown; quantity: 1).This report is for one (1) unk - nail head elements: tfna helical blade.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: h6.Investigation summary.The photo was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the x-ray image was reviewed, and the complaint condition is not confirmed.The tfna helical blade appears to be in the correct position per the photos provided.There are no signs of breakage of any of the components.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for unk - nail head elem: tfna helical blade.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot no lot number was provided or found in the photos, therefore no dhr could be performed.If a valid lot number is provided or the physical device returned, the dhr will be revisited.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

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.

• Brand Name: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• MDR Report Key: 12733477
• MDR Text Key: 284520347
• Report Number: 8030965-2021-09191
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: TFNA.; UNK - RODS.; UNK - SCREWS: NAIL DISTAL LOCKING.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR