MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown tomofix construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: takahara, y.Et al.(2021), good clinical outcomes and return to sports after hybrid closed-wedge high tibial osteotomy, knee surgery, sports traumatology, arthroscopy, vol.Xx, pages 1-10 (japan).This study aimed to investigate preoperative sports participation and postoperative clinical outcomes including a return to sports (rts) after hybrid closed-wedge high tibial osteotomy (cwhto) for medial compartment osteoarthritis (oa) of the knee.From january 2016 to december 2018, patients underwent cwhto for medial compartment oa.Plate fixation was performed using a tomofix locking plate (depuy synthes, switzerland) or a tris locking plate (olympus terumo biomaterials, japan).There were 126 patients with 46 males and 83 females.After discharge, outpatient follow-up was performed at 2, 3, and 6 months and 1 year after surgery at least.The following complications were reported as follows: 10 cases had fibular non-union.Of the 10 knees with fibular non-union after osteotomy, eight knees could return to sports.1 case had pain at fibular osteotomy.The patient was able to return to sports.1 case experienced discomfort at fibular osteotomy.The patient was able to return to sports.This report is for an unknown synthes tomofix construct.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12557730
• MDR Text Key: 274926196
• Report Number: 8030965-2021-08189
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention