MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN WRIGHT MEDICAL SCREW; SCREW, FIXATION, BONE

Catalog Number UNK_WWA

Device Problem Malposition of Device (2616)

Patient Problems Necrosis (1971); Implant Pain (4561)

Event Date 12/14/2021

Event Type  Injury  

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.Device not returned.

Event 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.".

Event 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 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.".

Manufacturer Narrative

The reported event (necrosis) could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN WRIGHT MEDICAL SCREW
• Type of Device: 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: 14380662
• MDR Text Key: 291973698
• Report Number: 3010667733-2022-00184
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention; Congenital Anomaly; Disability; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 52 KG