MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CAN ACET SCREW 20MM; PROST, HIP, SEMI-CNSTRND, MET/POLY, CMNTD

Model Number	71336520
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after surgery was completed, it was found that the content of the main code (01) field in the english logo of the univ can acet screw 20mm was "0", which was inconsistent with the content of the product (01) field.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was not returned for evaluation but the label pictures were reviewed, and the failure mode was confirmed.A complaint history review found related failures for the listed batch.A review of the manufacturing records and a labeling review indicated that the gtin was missing from the chartstik labels.At this time, we have determined that the product failed to meet product specifications at the time of manufacture.Some probable cause could be but not limited to incorrect system data input.An event evaluation concluded that a chart stick label change request was initiated in our system to update the corresponding label format.It was determined that the issue is isolated to the chart stick labels and does not impact the outer or inner labels.According to manufacturing procedures, barcodes are optional for chart stick labels.Thus, containment was not deemed necessary.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 future complaints and investigate as necessary.

• Brand Name: UNIV CAN ACET SCREW 20MM
• Common Device Name: PROST, HIP, SEMI-CNSTRND, MET/POLY, CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12537703
• Report Number: 1020279-2021-07204
• Device Sequence Number: 16497538
• Product Code: JDI
• UDI-Device Identifier: 03596010197658
• UDI-Public: 03596010197658
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K920430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 71336520
• Device Catalogue Number: 71336520
• Device Lot Number: 21CM15939
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1