MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5/4.5 MM LCP METAPHYSEAL PLATE; PLATE, FIXATION, BONE

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk - plates: 3.5/4.5 mm lcp metaphyseal plate/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, 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 (b)(6) as follows: this report is being filed after the review of the following journal article: park y., kim s.J., kim h.N., (2021) minimally invasive plate osteosynthesis using the oblong hole of a locking plate for comminuted distal fibular fractures, journal of orthopedic surgery and research volume xxxx, pages 1-8 (korea, south).This retrospective study aims to describe a novel technique that uses the oblong hole of a locking plate to lengthen the fibula for fracture reduction.Between may 2014 and june 2018, thirty-five consecutive patients 19 men and 16 women, with a mean age of 47.0 years (range, 20 to 72), who were treated with the minimally invasive plate osteosynthesis (mipo) technique for comminuted distal fibular fractures retrospectively studied.In patients with distal tibiofibular fractures, who were to be treated with mipo for both the tibia and fibula, the tibia was fixed first, due to increased difficulty in reduction of the tibia using closed reduction methods after fibular fixation.The correct length of a locking compression plate (lcp), namely, metaphyseal plate 3.5 (synthes, solothurn, switzerland), was chosen under c-arm image intensifier.One cortical screw was introduced in the most distal hole of the plate and inserted into the center of the distal fibula.Another long cortical screw was inserted into the center of the proximal fragment through the elongated hole as distally as possible, but not completely against the plate.Patients were followed up for a minimum of 1 year at regular intervals and were invited for a final follow-up office visit for the study.The mean duration of follow-up was 27.2 months (range, 12 to 58).The following complications were reported: one case of nonunion.The case with nonunion was combined with open distal tibial fracture that was treated by ilizarov external fixation.The tibia fracture was converted to intramedullary nailing, and the fibular nonunion was asymptomatic and did not require further surgery.This report is for an unknown synthes metaphyseal lcp plate 3.5.This report is for (1) unk - plates: 3.5/4.5 mm lcp metaphyseal plate.This report is 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: 3.5/4.5 MM LCP METAPHYSEAL PLATE
• 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: 12528447
• MDR Text Key: 273765381
• Report Number: 8030965-2021-08034
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 08/26/2021
• 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