MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC CLAW II 4 HOLE 25MM STERILE ORTHOLOC 3DSI; SCREW, FIXATION, BONE

Model Number	402S0425
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wrong item was inside the packaging.Operation completed with back up consignment implants on the shelf.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device was discarded.
Additional Manufacturer Narrative
The reported event could be confirmed, since imaging provided by the customer confirmed the claw ii 4 hole 25mm sterile ortholoc 3dsi was not in the package.Investigation determined it was a t-hole plate instead.It was also determined that a claw ii 4 hole t-hole lot was in a vibratory process within 12 minutes as the claw ii 4 hole 25mm sterile ortholoc 3dsi.Based on investigation, the root cause was attributed to a manufacturing process related issue.The failure was caused by comingling of two different plates during the vibratory process.A nonconformance investigation was initiated to investigate in further detail and determine any additional necessary actions.
Event or Problem Description
It was reported that the wrong item was inside the packaging.Operation completed with back up consignment implants on the shelf.

• Brand Name: CLAW II 4 HOLE 25MM STERILE ORTHOLOC 3DSI
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15756663
• Report Number: 3010667733-2022-00380
• Device Sequence Number: 20483331
• Product Code: HWC
• UDI-Device Identifier: 00840420152985
• UDI-Public: 00840420152985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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 Expiration Date: 08/21/2026
• Device Model Number: 402S0425
• Device Catalogue Number: 402S0425
• Device Lot Number: 1636048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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