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	Insufficient Information (4580)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the surgeon opened a evolve 7.5 +2 stem and inside the package was what looked like a 9.5 +2 stem.This delayed the process of implantation.Luckily we were able to go +2 with the head and standard stem to achieve the same tension.Would have been a different case if he used standard for both seeing as we only had one of each.
Event or Problem Description
It was reported that the surgeon opened a evolve 7.5 +2 stem and inside the package was what looked like a 9.5 +2 stem.This delayed the process of implantation.Luckily we were able to go +2 with the head and standard stem to achieve the same tension.Would have been a different case if he used standard for both seeing as we only had one of each.
Additional Manufacturer Narrative
Correction: d4 expiration date.The reported event could be confirmed, since a review of the dhr did find a deviation indicating a potential mix-up could have occurred during production.It was also determined that a second complaint with a similar allegation was received.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.

• 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: 14063798
• Report Number: 3010667733-2022-00154
• Device Sequence Number: 17374194
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 06/27/2022

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: 496S275
• Device Catalogue Number: 496S275
• Device Lot Number: 1704691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown