MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PHALINX STERILE MEDIUM 0 DG PHALINX HAMMERTOE SYSTEM; SCREW, FIXATION, BONE

Catalog Number	45A01003
Medical Device Problem Codes	Positioning Failure (1158); Separation Failure (2547); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
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
It was reported that the implant inserter will not release the implant once implanted.The implant is then ripped out of the middle phalanx when the surgeon tries to back the inserter out.The surgeon used an alice to screw in the implant.There was a 30 minute surgical delay.There is no adverse consequence to the patient but there is a concern that the implant will fall out and lead to a non-union.
Event or Problem Description
It was reported that the implant inserter will not release the implant once implanted.The implant is then ripped out of the middle phalanx when the surgeon tries to back the inserter out.The surgeon used an alice to screw in the implant.There was a 30 minute surgical delay.There is no adverse consequence to the patient but there is a concern that the implant will fall out and lead to a non-union.
Additional 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 for evaluation, another unit from the same lot was found in stock and pulled from inventory for inspection.Key dimensional measurements were taken that pertain to the allegation and all were found to be within specification.The test unit was functionally tested in a saw bone.Surgical technique was followed.Pilot hole was made with instruments in kit.Preloaded implant was inserted, rotated clockwise until inserter handle tip was flush with saw bone.Inserter was then removed from the implant without issue as intended.R&d was contacted regarding previous similar complaints.According to their review causes identified could be amount of pressure user was using to rotate implant into the bone.Page 8 of the optech notes while applying pressure, rotate the implant into the intermediate phalanx.(figure 7) for implant insertion.If the user used too much pressure it could have pushed 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.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 re-assessed.

• Brand Name: PHALINX STERILE MEDIUM 0 DG PHALINX HAMMERTOE SYSTEM
• 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: 19797091
• Report Number: 3010667733-2024-00455
• Device Sequence Number: 17180828
• Product Code: HWC
• UDI-Device Identifier: 00889797102155
• UDI-Public: 00889797102155
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K212996
• 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): 10/31/2024

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: Lay User/Patient
• Device Catalogue Number: 45A01003
• Device Lot Number: 107527
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2022
• 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