MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES; PLATE,FIXATION,BONE

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

Patient Problems Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/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.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: bain, g.I., galley, i.J., keogh, a.R.E., and durrant, a.W.(2010), axillary artery pseudoaneurysm after plate osteosynthesis for a clavicle nonunion: a case report and literature review, international journal of shoulder surgery, vol.4 (3), pages 79¿82 (australia).This study presents a case report of a (b)(6) year-old male patient who sustained a closed fracture to his nondominant left clavicle in 1998.He was treated non-operatively and went on to develop a symptomatic nonunion.Open reduction and bone grafting of the nonunion was performed in 1999 with a six-hole ao small fragment dynamic compression plate (dcp) (synthes).The clavicle united and his symptoms resolved.He presented 6 years after his surgery, with 18 months of progressively worsening pain, paraesthesia and claudication in his left hand.In the week prior to presentation, he noticed that his left hand was cool and pale.Clinically, he had a well-healed scar over his left clavicle with no associated mass or bruit.His left axillary artery was palpable.However, his brachial, radial and ulnar arteries were not.He had pain in the hand with exertion and poor capillary return.There were no trophic changes.His upper limb neurology was normal.Plain radiographs demonstrated a united clavicle with a six-hole plate superiorly.The medial screw was prominent inferiorly [figure 1].An arteriogram demonstrated the medial screw penetrating the axillary artery with an associated pseudoaneurysm [figure 2].There was occlusion of the brachial artery above the elbow [figure 3] with slow filling of the ulnar artery via collateral vessels.The radial artery and the proximal one-third of the ulnar artery were occluded.There was little flow past the metacarpophalangeal (mcp) joints.A computed tomography (ct) arteriogram confirmed penetration of the axillary artery by the prominent medial screw, with an associated pseudoaneurysm [figures 4 and 5].The patient was anticoagulated following plate removal [figure 6].The prominent medial screw measured 26 mm.The pseudoaneurysm was bypassed using a stent placed in the axillary artery via a femoral approach.The self-expanding stent is constructed with a durable, reinforced biocompatible, expanded polytetrafluoroethylene (eptfe) liner attached to the external nitinol stent structure.The stent was dilated using a 7 mm×40 mm balloon [figure 7].This report is for an unknown synthes dynamic compression plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11554892
• MDR Text Key: 257205196
• Report Number: 8030965-2021-02206
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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: 02/24/2021
• 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: 32 YR