MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EX-FIX; SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown external fixator unknown lot.Part and lot number 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.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: cibula, z.Et al.(2020), complex open elbow fracture gustilo-anderson type iiib treated with the primary elbow arthroplasty: a case report, chinese journal of traumatology, vol.Xx, pages 1-5 (slovakia).This study presents a case report of a (b)(6) year-old male patient who suffered cervical column fracture, the ribs fractures, the lung contusion, the spleen contusion, the duplex fracture of the left femur, the scapula fracture and the complex open fracture of the left elbow gustilo anderson type iiib.The irreparable loss of ulnar nerve and the loss of distal triceps with insertion was diagnosed.The bridging external fixator (synthes gmbh, oberdorf, (switzerland) on the left elbow with the vac system (vivanotec, hartmann, heidenheim, germany) on the soft tissues defect was used.Two weeks after the injury, patient received intravenous (iv) ampicillin 2 g every 6 h for 3 weeks and iv voriconazol 300 mg every 12 h for 10 days.Debridement, irrigation and vac system exchange was performed 3 times after each 5e6 days.The microbiological finding from the defect was positive presence of staphylococcus haemolyticus was observed.So, iv vancomycin 1 g every 12 h for 10 days was added.Five weeks after the injury, when the overall wound state was satisfactory and the repetitive microbiological findings was negative, the soft tissue defect was covered with fascia e cutaneous flap from the forearm.After the surgery, the external fixator was removed, and the left upper extremity was immobilized with the cast for 2 weeks.The wounds healed primary (per primam intentionem) without any sign of infection.This report is for an unknown synthes external fixator.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EX-FIX
• Type of Device: SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
• 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: 11474552
• MDR Text Key: 250245787
• Report Number: 8030965-2021-01914
• Device Sequence Number: 1
• Product Code: NDK
• Combination Product (y/n): N
• Reporter Country Code: LO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/12/2021
• 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
• Patient Age: 39 YR