MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 10MM; NAIL, FIXATION, BONE

Model Number	71634010
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Failure of Implant (1924)
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.When the third nail cap was replaced, it was directly stuck with the driver and could not be removed, and it cracked when it was just 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 not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: NAIL CAP 10MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10826156
• Report Number: 1020279-2020-06400
• Device Sequence Number: 14344975
• Product Code: JDS
• UDI-Device Identifier: 03596010495723
• UDI-Public: 03596010495723
• 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): 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71634010
• Device Catalogue Number: 71634010
• Device Lot Number: 18EM15605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention