MAUDE Adverse Event Report: SYNTHES GMBH UNK - DISTRACTOR PINS; APPLIANCE, FIXATION, NAIL

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

Patient Problems Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 04/12/2015

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown distractor pins/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.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.

Event Description

This report is being filed after the review of the following journal article: kriegelstein s, et al.(2015), managing mid-foot instability of charcot foot with ring fixator, oper orthop traumatol 2015, volume 27, page 129-138, (germany) the goal of the method is to use external treatment with a ring fixator to stabilize internal osteosynthesis and support load-bearing osseous healing.A total of 20 patients, with charcot arthropathy of the midfoot and uninfected foot ulcer treated conservatively within a period of six months using combined internal (screw/ plate osteosynthesis) and external (ring fixator) arthrodeses, were included in the study.There were 10 men with a mean age of 59.7 years and 10 women with a mean age of 63.2 years.Resection arthrodesis in the areas of the midfoot was done using a competitor¿s devices.In order to protect the internal fixation, an unknown synthes external ring fixator was applied, which also uses a walking frame.Postoperative management included postoperative partial weight bearing with sole contact and walking frame for 3 months.Then removal of external fixator, ct scan and based on the result, staged increasing of stress load with short-leg cast over a period of 4¿6 weeks.Podomechanotherapy with full weight bearing.The average post-operative follow-up observation period was an average 12.2 months.After 3 and 6 months a clinical and radiological examination as well as inspection of the aids used.Complications were reported as follows: 7 patients had complications with wound disruptions that could be treated using conservative wound therapy.11 patients had wound healing disruptions, pin infections or dislocations and required new treatment.Of these, 5 patients were treated using wound revision or pin removal.5 patients had persistent postoperative ulcers.This report is for the unknown synthes external ring fixator pins.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - DISTRACTOR PINS
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 11641757
• MDR Text Key: 245874298
• Report Number: 8030965-2021-02746
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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: 03/11/2021
• 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