MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 13MM X 32CM 130D RT; NAIL, FIXATION, BONE

Model Number	71675430
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nail was expired and implanted.It wasn't caught until after implanted.It was opened by the nurse and wasn't caught by myself, nurse or scrub.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The nail remains implanted.A visual of the provided photo confirmed the part and batch info.The nail was manufactured in 2009.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Expiration info was verified to be correct.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Potential probable causes that could contribute to the reported event have been identified as user error.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: INTERTAN 13MM X 32CM 130D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9235724
• Report Number: 1020279-2019-03738
• Device Sequence Number: 13557671
• Product Code: JDS
• UDI-Device Identifier: 00885556038154
• UDI-Public: 00885556038154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 02/10/2019
• Device Model Number: 71675430
• Device Catalogue Number: 71675430
• Device Lot Number: 09BM08837
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1