MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 7.5MM +2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number	496S275
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer opened a 7.5 +2 stem, the box says that, the product even has the correct code stamped on it however the actually stem is larger.Customer didn¿t have the same size, needed to resect more bone from the patient and use a +4 stem.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device was found to have incorrect dimensions.Examination finds the etching on the device to be catalog: 496s275, lot 1704691.Dimensional inspection of the stem found the measurement to be 9.48mm not 7.5mm as indicated by the catalog 496s275 specifications.A review of the dhr did find a deviation indicating a potential mix-up could have occurred during production.Based on investigation, the root cause was attributed to a manufacturing related issue.The failure was caused by an apparent mix-up during quality inspections prior to the laser marking process.A nonconformance was opened to further investigate the issue.
Event or Problem Description
It was reported that customer opened a 7.5 +2 stem, the box says that, the product even has the correct code stamped on it however the actually stem is larger.Customer didn¿t have the same size, needed to resect more bone from the patient and use a +4 stem.

• Brand Name: EVOLVE STEM 7.5MM +2
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14680374
• Report Number: 3010667733-2022-00206
• Device Sequence Number: 11921136
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 496S275
• Device Catalogue Number: 496S275
• Device Lot Number: 1704691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown