MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC P/S CAM MODULE SZ 3; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71433363
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, a labeling discrepancy was found on one of the instrument.On the packaging and the device, the item number is indicated correctly (size 3), but, a different size (6) is indicated on the product.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirms the laser mark on the device shows size 6 when the packaging shows size 3.The device returned on this complaint was confirmed to be partially laser etched by s+n and packaged as a size three.The supplier etches the size and description and s+n etches the ci, batch, ce, and gtin.The returned part is confirmed to be a size 6 which is correct according to the supplier laser etching.S+n laser etched information for size three parts.A mix occurred prior to the s+n laser etch operation.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: GII SPC P/S CAM MODULE SZ 3
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11646912
• Report Number: 1020279-2021-02870
• Device Sequence Number: 14302096
• Product Code: MBH
• UDI-Device Identifier: 00885556032732
• UDI-Public: 00885556032732
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K121393
• 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): 07/12/2021

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: 71433363
• Device Catalogue Number: 71433363
• Device Lot Number: 20HM10589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1