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

Catalog Number	71634000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, when the cap was screwed on the nail implanted on the patient the cap began to crack on the head until it was broken.Delay was not specified.No injury reported.Doctor decided to leave the nail without cap.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The head of the device fractured, but remained together, so no pieces are missing.The device was manufactured in 2018.The product evaluation found the device to have been cross-threaded during use, which could have contributed to the failure.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: NAIL CAP {} 0MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8651734
• Report Number: 1020279-2019-02089
• Device Sequence Number: 2117868
• Product Code: JDS
• UDI-Device Identifier: 03596010495709
• UDI-Public: 03596010495709
• Combination Product (Y/N): N
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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 Catalogue Number: 71634000
• Device Lot Number: 18EM23057
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1