MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN - PINS/WIRES; WIRE, SURGICAL

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - pins/wire/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 product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 germany as follows: this report is being filed after the review of the following journal article: schimmer, c.Et al.(2007), large thoracic wall hematoma following sternal reconstruction with transversal plate fixation after deep sternal wound infection, thoracic cardiovascular surgery, vol.55, pages 401-405 (germany).This study presents a case report of a (b)(6) year-old male patient who underwent aortic and mitral valve replacement with mechanical prostheses (avr + mvr), combined with coronary artery bypass grafting (cabg).On postoperative day 13, the patient had to be taken back into the operating room (or) with typical signs of sternal instability and deep sternal wound infection (dswi).The osteosynthesis of the sternum halves had loosened and putrid infection was present at the sternal level and also in the anterior mediastinal space.After inflammation parameters had declined, negative bacteriological cultures could finally be obtained and all tissues presented as clean and granulating surfaces, the sternal bone being largely intact after resection of only marginal necrosis.Thus, on postoperative day 38, we performed transverse plate fixation with the synthes® sternal fixation system (synthes gmbh, umkirch, germany).Wound healing was uneventful.Sixteen days later the patient was readmitted to the emergency room due to a large and rapidly progressive, painful tumescence above the sternum, evolving suddenly after physiotherapeutic treatment.Ct scans showed a large parasternal, unmuscular hematoma.As a possible cause, the ct showed an exit of contrast fluid, eventually matching up to a small bleeding vessel.Emergency surgery was scheduled.The only explanation for the bleeding was that the small vascular lesion had been caused by one of the midline cotters pins of the titanium plates.Wound healing was again uneventful.At the first follow-up visit in our outpatient clinic 3 months later, the patient showed up with a completely healed wound and a solid sternum, with no complaints and no recurrent bleeding.This report is for an unknown synthes sternal fixation.This report is for one (1) unknown extraction instrument.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN - PINS/WIRES
• Type of Device: WIRE, SURGICAL
• 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: 12689414
• MDR Text Key: 278152982
• Report Number: 8030965-2021-08935
• Device Sequence Number: 1
• Product Code: LRN
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR