MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC VLP 3.5MM X 48MM CRTX SCRW S-T; PLATE, FIXATION, BONE

Catalog Number	71821348
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the item had the wrong item number on the package.This was discovered after the case.No patient affectation or delays reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The incorrect catalog number was on the package label.The device was manufactured in 2019.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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: PERI-LOC VLP 3.5MM X 48MM CRTX SCRW S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9295887
• Report Number: 1020279-2019-03927
• Device Sequence Number: 19513588
• Product Code: HRS
• UDI-Device Identifier: 03596010625595
• UDI-Public: 03596010625595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 71821348
• Device Lot Number: 19HM05346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1