MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN X-FUSE IMPLANT; PIN, FIXATION, SMOOTH

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neuropathy (1983)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance pmcf study review.The alleged neuropathic pain on the scar at final follow-up of 3 months included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by (b)(6).The title of this report is ¿analysis of a retrospective data collection of 100 dip fusion or thumb ip fusion with the implant x-fuse®¿, which is associated with the stryker ¿x fuse® superelastic implant¿ system.This report includes analysis of the clinical data that was collected on 86 patients, the cases in this study range from january 2018 and december 2020.During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available.It was reported that one patient experienced neuropathic pain on the scar at final follow-up of 3 months.The report states: ¿one patient had a neuropathic pain on the scar.This complication cannot be related to the implant but was related to the operation.The patient could return to normal activities after 3 months despite his pain.¿.

• Brand Name: UNKNOWN X-FUSE IMPLANT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13265829
• MDR Text Key: 287022792
• Report Number: 0008031020-2022-00011
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2021
• Initial Date FDA Received: 01/17/2022
• 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