MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TAILOR'S BUNION IMPLANT MED PROSTEP TAILOR'S BUNION; SCREW, FIXATION, BONE

Model Number	977TIMPM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Necrosis (1971); Implant Pain (4561)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that,"your prostep medullary rod toggles in the metatarsal bone shaft, destroying my metatarsal bone.I need bone grafting.The screw that should have been secured in the distal osteotomy segment was in soft tissue causing nonunion and avn.I developed extreme pain and a palpable screw head.The intramedullary implant was loose and toggling as early as post op weeks 1 and 3.The podiatrist would not disclose the problem until i discovered it at week 16.I will have numerous surgeries revisions and bone grafting patient will have a revision on (b)(6) 2022 to have a screw removed and have the rod out of metatarsal shaft.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not returned.
Additional Manufacturer Narrative
The reported event (implant - loosening postoperative) could be confirmed, since revision operative reports were provided that indicate the allegation as the reason for revision.Although the allegation could be confirmed, a definitive root cause could not be determined.Radiographic images provided were post revision.Without images post initial implant and pre revision, no further assessment can be made.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 or Problem Description
It was reported by the patient that,"your prostep medullary rod toggles in the metatarsal bone shaft, destroying my metatarsal bone.I need bone grafting.The screw that should have been secured in the distal osteotomy segment was in soft tissue causing nonunion and avn.I developed extreme pain and a palpable screw head.The intramedullary implant was loose and toggling as early as post op weeks 1 and 3.The podiatrist would not disclose the problem until i discovered it at week 16.I will have numerous surgeries revisions and bone grafting patient will have a revision on (b)(6) 2022 to have a screw removed and have the rod out of metatarsal shaft.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported on mw5109312 by the patient that,"your prostep medullary rod toggles in the metatarsal bone shaft, destroying my metatarsal bone.I need bone grafting.The screw that should have been secured in the distal osteotomy segment was in soft tissue causing nonunion and avn.I developed extreme pain and a palpable screw head.The intramedullary implant was loose and toggling as early as post op weeks 1 and 3.The podiatrist would not disclose the problem until i discovered it at week 16.I will have numerous surgeries revisions and bone grafting patient will have a revision on (b)(6) 2022 to have a screw removed and have the rod out of metatarsal shaft.".

• Brand Name: TAILOR'S BUNION IMPLANT MED PROSTEP TAILOR'S BUNION
• 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: 14380620
• Report Number: 3010667733-2022-00183
• Device Sequence Number: 6725215
• Product Code: HWC
• UDI-Device Identifier: 00889797075985
• UDI-Public: 00889797075985
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2023

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: Lay User/Patient
• Device Model Number: 977TIMPM
• Device Catalogue Number: 977TIMPM
• Device Lot Number: 1716067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 06/13/2023
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 08/08/2022; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 52 KG