MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CABLE/WIRE; CERCLAGE FIXATION

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cable-wire / unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: gunadham, u.And kongkreangkrai, t.(2019), femoral artery entrapment after cerclage wiring of distal femoral shaft fracture: a case report, journal of orthopaedics, trauma and rehabilitation, vol.26 (1), pages 39-42, https://doi.Org/10.1016/j.Jotr.2018.05.004, (thailand).This study presents a case report of an (b)(6) year-old female patient who had a displaced, oblique fracture of the distal shaft of the left femur.She underwent open reduction and internal fixation with distal femur locking compression plate augmented with cerclage wiring (figure 2).During cerclage wiring, the single wire was placed in regular subperiosteal fashion with the assistance of a standard l-size cerclage passer (depuy synthes, pa) (figure 3).Six hours after the operation, her left leg was colder than the other side without severe pain.Her dorsalis pedis and posterior tibial pulse were absent when detected by both palpation and doppler ultrasound.Computed tomography angiogram was performed and revealed superficial femoral artery entrapment by cerclage wire on her left femur with near-total occlusion (figure 4).Emergency cerclage wire removal and femoral artery exploration were performed and found that the cerclage wire belted directly over superficial femoral artery with some muscle tissue encasement.After cerclage removal, the superficial femoral artery had normal flow, and both dorsalis pedis and posterior tibial pulse could be palpated.This report is for an unknown synthes wires.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CABLE/WIRE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9167855
• MDR Text Key: 168215207
• Report Number: 8030965-2019-69157
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 09/19/2019
• 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: 80 YR
• Patient Weight: 42