MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 0MM; NAIL, FIXATION, BONE

Model Number	71634000
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure when the tibial intramedullary nail was finally put on the nail cap, there was a problem with the thread of the nail cap, which could not be screwed in.Surgery was completed with an s+n backup device.No information about injuries or surgical delays were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms the stated failure.The threads are damaged on the nail cap.The device was manufactured in 2019.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 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 CAP 0MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10825980
• Report Number: 1020279-2020-06394
• Device Sequence Number: 3334525
• Product Code: JDS
• UDI-Device Identifier: 03596010495709
• UDI-Public: 03596010495709
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 71634000
• Device Catalogue Number: 71634000
• Device Lot Number: 19FM18207
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1