MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL PROX DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71751131
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during inspection, it was noticed that the nail prox drop is coming apart, guide was not targeting the nail.The procedure was finished using the same device.There was a delay less than or equal to 30 minutes.No harm to the patient reported.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is worn with scratches on the surface.The device shows signs of extensive use.A functional evaluation confirmed that this device was paired with mating part mechanism and does not function as intended.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection confirmed that the returned complaint part is 10 years old and exhibits signs of significant wear/usage.Normal, repetitive use of the product has caused the epoxy/adhesive, which holds the two parts of the drop together, to break down and come loose, allowing for the drop to come apart as described in the notes.Nothing dimensional appears to be out - with the one part not staying inside of the other, it can shift and cause the nail not to target correctly.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: NAIL PROX DROP
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10979056
• Report Number: 1020279-2020-07295
• Device Sequence Number: 14058417
• Product Code: HSB
• UDI-Device Identifier: 03596010515438
• UDI-Public: 03596010515438
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 71751131
• Device Catalogue Number: 71751131
• Device Lot Number: 11LCL0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1