MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PHALINX STERILE X-SMALL 0 DG PHALINX HAMMERTOE SYSTEM; PIN, FIXATION, SMOOTH

Catalog Number 45A01001

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

As reported: we opened an xs and the doctor couldn't remove the implant from the handle.After further examine/trying to pull out the implant with different instruments, we realized the implant was stuck and looked like 75% of the implant was pushed into the handle vs the typical 50%.Ended up opening another xs and used it.".

Manufacturer Narrative

Based on the available information the device will not be returned; therefore, an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Although the complaint device was not returned, a unit from the same lot was available in stock for evaluation.Evaluation of the stock item found the sub components to be within print specifications and were fully functional.More detailed information about the complaint event as well as the affected device 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: we opened an xs and the doctor couldn't remove the implant from the handle.After further examine/trying to pull out the implant with different instruments, we realized the implant was stuck and looked like 75% of the implant was pushed into the handle vs the typical 50%.Ended up opening another xs and used it.".

• Brand Name: PHALINX STERILE X-SMALL 0 DG PHALINX HAMMERTOE SYSTEM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17726052
• MDR Text Key: 323154948
• Report Number: 3010667733-2023-00525
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00889797102131
• UDI-Public: 00889797102131
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 45A01001
• Device Lot Number: 107541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1