MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE HEAD 26MM; PROSTHESIS, ELBOW,HEMI-, RADIAL,POLYMER

Catalog Number	496H026
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Device had incomplete and compromised sterile packaging.
Additional Manufacturer Narrative
Correction: please refer h3 device evaluated by mfg the reported event could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned product confirms the catalog and lot number.The product was returned in an opened condition.There is visible damage to the outer carton box including creases and slight tears around the edges of the box.The back of the box is scratched with portions of the surface visibly worn away.This damage most likely resulted from rough handling during transport or storage indicating the outer packaging experienced some form of impact or abrasion.The inner sterile packaging appears significantly wrinkled and was found opened as reported.An attempt was made to retrieve and inspect a product from the same lot.However, none were found in stock.Since the product was returned in an opened condition, the root cause of the reported issue could not be conclusively determined.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
Device had incomplete and compromised sterile packaging.

• Brand Name: EVOLVE HEAD 26MM
• 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: 19940771
• Report Number: 3010667733-2024-00490
• Device Sequence Number: 14671723
• Product Code: KWI
• UDI-Device Identifier: 00840420126085
• UDI-Public: (01)00840420126085(11)201118(17)281116(10)1696464
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 496H026
• Device Lot Number: 1696464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/26/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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