MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TOMOFIX OSTEOTOMY; PLATE, FIXATION, BONE

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

Patient Problems Bone Fracture(s) (1870); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Report is for an unk - plates: tomofix osteotomy /unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: goshima k., (2020) factors associated with patient satisfaction after opening-wedge high tibial osteotomy, the orthopedic journal of sports medicine, 8(11),pages 1-10 (japan) syunsuke5552000jp@yahoo.Co.Jp this retrospective case series aims to evaluate patient subjective satisfaction after owhto and determine the pre- and postoperative factors associated with patient satisfaction after owhto.Between january 2011 and december 2016, 141 consecutive patients (151 knees) (51 males, 100 females) age 64.3 ± 10.4 (22 to 83 years ) who underwent owhto were enrolled in this study.Some patients were excluded.In total, 123 patients (36 males, 87 females) age 63.8 ± 10.5 (22 to 83 years ) were included in this study.Fixation was done using a tomofix plate (depuy synthes) was inserted into a subcutaneous tunnel that was formed on the medial side of the tibia and was fixed in place with 8 locking screws.Final cohort were followed up at 54.6 ± 20.6 (25 to 100) months.The following complications were reported: - additional surgery was required for 5 complications, including delayed infection (n =3), overcorrection (n =1) and late lateral hinge fracture (n =1).- wblr significantly changed from20.7% ± 11.8% (range, _25.9% to 46.0%) preoperatively to 66.9%± 10.2%(range, 33.1%to 100%) at the final follow-up.- of the 123 patients, 115 underwent hardware removal, and arthroscopic evaluation was performed during plate removal.This report is for an unknown synthes tomofix plate with 8 locking screws.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - plates: tomofix osteotomy this report is 1 of 4 for (b)(4).

• Brand Name: UNK - PLATES: TOMOFIX OSTEOTOMY
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12543880
• MDR Text Key: 273772394
• Report Number: 8030965-2021-08101
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: 08/31/2021
• 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