MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC IMPLANT MEDIUM CANNULATED PHALINX HAMMERTOE; SCREW, FIXATION, BONE

Catalog Number	45301003
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the implant was ripped out of the patients bone during removal of the handle in a hammertoe surgery.The implant was still used in the patient but with less bone purchase.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The optech notes ¿while applying pressure, rotate the implant into the intermediate phalanx for implant insertion." and "the implant should be screwed into the intermediate phalanx until the distal tip of the handle is flush with the bone.The handle can then be removed from the implant." if the user applies too much pressure it could push the implant further into the housing/handle and cause it to wedge inside and become stuck.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.No corrective actions are required at this time.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the implant was ripped out of the patients bone during removal of the handle in a hammertoe surgery.The implant was still used in the patient but with less bone purchase.

• Brand Name: IMPLANT MEDIUM CANNULATED PHALINX HAMMERTOE
• 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: 18852157
• Report Number: 3010667733-2024-00138
• Device Sequence Number: 12626907
• Product Code: HWC
• UDI-Device Identifier: 00840420166043
• UDI-Public: 00840420166043
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Catalogue Number: 45301003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Male